AveragePenny
3週前
$SSII SS Innovations Announces Completion of BDO Audit Process and Issues Update on Plans for NASDAQ Uplisting
https://www.globenewswire.com/news-release/2024/12/11/2995695/0/en/SS-Innovations-Announces-Completion-of-BDO-Audit-Process-and-Issues-Update-on-Plans-for-NASDAQ-Uplisting.html
FORT LAUDERDALE, Fla., Dec. 11, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, today announced that its new independent registered public accounting firm, BDO India LLP (“BDO”), has completed the re-audit of the Company’s consolidated financial statements for the years ended December 31, 2023 and December 31, 2022, which were included in the Company’s previously filed Annual Report on Form 10-K for the year ended December 31, 2023 (the “Original Filing”). In addition, SS Innovations is hereby updating its shareholders and the investment community on its plans to uplist its common stock to NASDAQ.
As previously reported in its Securities and Exchange Commission (“SEC”) filings, in May 2024, the SEC entered an order barring BF Borgers CPA PC (“Borgers”), the Company’s then independent registered public accounting firm, from appearing or practicing before the SEC as an accountant. As a result, Borgers could no longer act as the independent registered public accounting firm for the Company (or several hundred other public companies who had also engaged Borgers). Consequently, the Company terminated the engagement of Borgers and subsequently retained BDO as its independent registered public accounting firm.
Given the circumstances giving rise to Borgers’ dismissal, the Company asked BDO to re-audit the prior consolidated audited financial statements included in the Original Filing. Contemporaneously with the reaudit, the Company also undertook an internal review of certain accounting policies and internal controls and procedures. An external consulting firm was also appointed by the Company to help perform comprehensive technical accounting evaluations.
In the course of this internal review and while BDO was performing the reaudit, the Company discovered material errors in the prior audited consolidated financial statements included in the Original Filing. As a result, the Company determined that in order to reflect the foregoing, those financial statements would need to be restated and as a result could no longer be relied upon (which was reported in a Current Report on Form 8-K filed with the SEC).
On December 6, 2024, SS Innovations filed an amendment to the Original Filing on Form 10-K/A, which included audited consolidated financial statements and related footnote disclosures as of and for the years ended December 31, 2023, and 2022, which restated the financial statements included in the Original Filing.
Restated consolidated financials for 2023 post BDO audit as per the recently filed 10K/A had the following major differences from the Original Filing:
Major areas of change As per Original Filing As per Form 10-K/A Difference
Balance Sheet as of December 31, 2023
Shareholders’ Equity $14.30 Mill $19.72 Mill Increase by $5.42 Mill
Working Capital Surplus $ 9.11 Mill $12.96 Mill Increase by $3.85 Mill
Statement of Operations and Comprehensive Loss for the year 2023
Revenues for 2023 $ 5.88 Mill $ 5.88 Mill No change
Gross Profits $ 0.71 Mill $ 0.72 Mill Increase by $0.01 Mill
Loss from Operations $ 20.67 Mill $ 20.27 Mill Decrease by $0.40 Mill
Total Comprehensive Loss $ 21.29 Mill $ 21.13 Mill Decrease by $0.16 Mill
The abovementioned changes in reported financials were mainly due to the following reasons:
Change in accounting for the April 2023 acquisition by merger of Cardio Ventures, Inc.
Change in revenue recognition for deferred payment sales.
Functional and other reclassifications.
Recognition of right of use of certain assets and liabilities.
Corrections of certain errors/adjustments.
The net impact of the restatements as mentioned above resulted in reporting of an improved net worth position and slightly improved financial performance numbers of the Company for the year 2023.
Contemporaneously with this filing, the Company filed with the SEC to withdraw its pending Registration Statement on Form S-1, which was filed on February 14, 2024. The Company believes that it meets the requirements for listing its shares of common stock on NASDAQ without completing the offering contemplated by the Registration Statement and intends to proceed with an uplisting to NASDAQ or another National Securities Exchange as soon as possible.
SS Innovations continues to demonstrate its accelerating growth having successfully completed to date over 2,500 robotic surgical procedures primarily in India using its SSi Mantra Surgical Robotic System (the “SSi Mantra”) and its recently announced expansion to Indonesia where it successfully completed that country’s first robotic cardiac surgery using its SSi Mantra. SS Innovations now has its systems installed in 5 countries and expects to continue its expansion to fulfill its mission to provide affordable state-of-the-art robotic surgery treatment to patients around the globe.
AveragePenny
4週前
$SSII India’s First CDSCO Certified Robotic System for Telesurgery: SSi Mantra Leads the Way
https://www.globenewswire.com/news-release/2024/12/10/2994648/0/en/India-s-First-CDSCO-Certified-Robotic-System-for-Telesurgery-SSi-Mantra-Leads-the-Way.html
SS Innovations becomes the first and only company in India to receive regulatory approval for Telesurgery and Teleproctoring capabilities of a surgical robotic system, its SSi Mantra, marking a significant achievement in surgical robotics
SS Innovations reinforces India's position as a hub for technological innovation in healthcare using the SSi Mantra - Made in India, for the World
The SSi Mantra integrates innovative advancements in robotic surgery, offering surgeons enhanced precision and control for improved patient outcome
FORT LAUDERDALE, Fla., Dec. 10, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (OTC: SSII) (“SS Innovations” or the “Company”), a developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable for and accessible to a global population, has achieved a milestone in Indian medical science by becoming the first and only company in India to receive Central Drugs Standard Control Organization (CDSCO) regulatory approval for Telesurgery and Teleproctoring capabilities of a surgical robotic system, its SSi Mantra, signifying a significant achievement in surgical robotics. The CDSCO is India’s equivalent to the United States Food and Drug Administration (FDA).
This achievement positions the SSi Mantra as the first surgical robotic system in India authorized to perform surgical procedures using these advanced capabilities. It paves the way for SS Innovations' commitment to advancing robotic surgical technology, making cutting-edge procedures more accessible, and reinforcing the position of India as a leader in healthcare innovation.
Telesurgery, first envisioned in the 1980s for use in space and on remote battlefields, faced significant challenges due to the technological limitations and lack of bandwidth available at the time. Today, with advancements in both technology and connectivity, SS Innovations has turned this vision into reality with its innovative SSi Mantra Surgical Robotic System. By integrating Telesurgery and Teleproctoring capabilities, the SSi Mantra aims to decentralize and democratize access to robotic surgical expertise, addressing critical gaps in healthcare, particularly in remote areas, where access to specialized medical care has often been a challenge.
Celebrating this achievement, SS Innovations Founder, Chairman, and CEO, Dr. Sudhir Srivastava, said, “Reaching this milestone with the SSi Mantra is a testament to our vision of transforming surgical practices, enhancing access, and driving the adoption of robotic surgery. Telesurgery and Teleproctoring have been a dream in the making for over four decades, and today, it has finally come to life. With the technology and bandwidth available now, we can truly decentralize and democratize surgical expertise, reaching patients and surgeons in the most remote parts of India and the world. We believe that this innovation is a game-changer, especially for our country, where much of the population lives in smaller towns and rural areas. By enabling remote surgical treatment, we are reshaping the future of healthcare.”
This achievement marks a significant step forward in India’s healthcare landscape, with SS Innovations at the forefront of revolutionizing surgical care through state of the art technology. The approval of Telesurgery and Teleproctoring capabilities for the SSi Mantra not only underscores the Company’s commitment to innovation but also opens up new possibilities for accessible, high-quality healthcare across India and beyond. As SS Innovations continues to expand the boundaries of medical technology, it remains dedicated to transforming healthcare delivery, making advanced treatments more accessible and more economical, thereby improving the lives of patients worldwide.
AveragePenny
4月前
$SSII SS Innovations International, Inc. Announces First Mantra Surgical Robotic System Sale in South America
https://www.globenewswire.com/en/news-release/2024/09/03/2939800/0/en/SS-Innovations-International-Inc-Announces-First-Mantra-Surgical-Robotic-System-Sale-in-South-America.html
SS Innovations receives Regulatory Approval for Clinical Use in Ecuador
SS Innovations Partners with Medical Device Firm Ingemedica S.A. for Distribution in Ecuador
The first SSi Mantra Surgical Robotic System to be installed at Interhospital, Guayaquil City, Ecuador
FORT LAUDERDALE, Fla. , Sept. 03, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, announced that it has completed the first sale of its SSi Mantra Surgical Robotic System in Ecuador as it begins its sales efforts in Central and South America.
SS Innovations successfully received the Ecuadorian regulatory approvals for clinical use in May 2024. Following the approvals, ongoing efforts to bring the Company’s affordable surgical robotic system to Ecuador began to solidify. Through SS Innovation’s partnership with Ingemedica Del Ecuador S.A., the Company’s distribution partner in Ecuador, the first purchase order was placed in August 2024 by Interhospital, a large multispecialty hospital in Guayaquil City, Ecuador.
Juan Pablo Rovayo, Sales and Project Manager for Ingemedica Del Ecuador S.A., commented, “The acquisition of the SSi Mantra Robotical Surgical System by Interhospital represents a significant advancement for the healthcare system in Ecuador. The SSi Mantra, designed with the philosophy of making high-tech surgery affordable for everyone, not only places Ecuador at the forefront of modern medicine but also reinforces Interhospital's commitment to accessibility and quality in healthcare. The SSi Mantra offers numerous advantages, such as advanced surgical precision that reduces recovery times and minimizes postoperative complications. This not only improves the experience and outcomes for patients but also optimizes hospital resources by reducing prolonged stays and the need for additional interventions.”
Mr. Rovayo further added, “The incorporation of this technology can make complex surgeries more accessible, eliminating the economic barriers that traditionally limit many patients. By making these surgeries more affordable, Interhospital not only elevates its level of service but also contributes to the overall well-being of the population, aligning with its mission to offer excellent healthcare to all Ecuadorians.”
SS Innovations’ President and COO, Dr. Vishwa Srivastava, said, “We are very excited to announce that we have completed our first SSi Mantra Surgical Robotic System sale in South America. We are very excited for the opportunity to extend our Company’s vision beyond borders and across continents. I am confident that the surgeons at Interhospital in Ecuador will be able to utilize our technology to best serve the patients in their community, offering the highest level of surgical care at an affordable cost, making our innovative technology accessible to all in Ecuador. As we are launching in South America, representing another part of the world that has tremendous inequity of healthcare access amongst its population, this expansion serves as a potent reminder and validation of our vision and mission to address the global need for affordable and accessible world-class robotic surgery. It is this same reminder that drives us forward at SS Innovations as a digital healthcare company in order to democratize global access to the latest technologies.”
The SSi Mantra Surgical Robotic System has received regulatory approvals in India, Indonesia, Nepal, Guatemala and now, Ecuador. It has been clinically utilized in over 1,900 cases in more than 80 different surgical procedures. SS Innovations has initiated the regulatory approval process in the United States and the EU, with approvals to market anticipated in the second half of 2025.
AveragePenny
4月前
$SSII SS Innovations Issues Update on Status of Audit Process and Trading Market for Common Stock
https://www.globenewswire.com/en/news-release/2024/08/30/2938518/0/en/SS-Innovations-Issues-Update-on-Status-of-Audit-Process-and-Trading-Market-for-Common-Stock.html
FORT LAUDERDALE, Fla., Aug. 30, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, today issued an update to its shareholders and the investment community on the status of its audit process and the trading market for its common stock.
As previously reported in its Securities and Exchange Commission (“SEC”) filings, in May 2024, the Securities and Exchange Commission entered an order barring BF Borgers CPA PC (“Borgers”), the Company’s then independent registered public accounting firm, from appearing or practicing before the SEC as an accountant. As a result, Borgers could no longer act as the independent registered public accounting firm for the Company (or several hundred other public companies who had also engaged Borgers). Consequently, the Company terminated the engagement of Borgers and retained BDO India (“BDO”) as its independent registered public accounting firm.
Given the circumstances giving rise to Borgers’ dismissal, the Company asked BDO to re-audit the Company’s financial statements as of and for the years ended December 31, 2023 and December 31, 2022, and contemporaneously therewith undertook an internal review of certain accounting policies and internal controls and procedures.
In the course of this internal review and while BDO is performing the reaudit, the Company determined and reported in an August 14, 2024 Form 8-K filing with the SEC that, among other items, it would restate its audited financial statements for the years ended December 31, 2023 and December 31, 2022 and its interim unaudited financial statements for the quarters ended March 31, 2023, June 30, 2023, September 30, 2023 and March 31, 2024. Please refer to the August 14, 2024 Form 8-K filing for full details.
The Company is working diligently with BDO to complete the audit and the restated financial statements and file the required amendments to its SEC reports. Moreover, as further reported by the Company in its August 14, 2024 Form 8-K filing, the Company’s Form 10-Q Quarterly Report for the quarter ended June 30, 2024 would not be filed on a timely basis.
As the Company was not able to meet the filing deadline, OTC Markets, Inc. moved the Company’s common stock from the OTC Pink Tier of the over-the-counter market to the Expert Market Tier.
The Expert Market is an extremely limited market for OTC companies that are not current in their filing requirements. It is used by broker-dealers to publish quotes from customer limit orders. The public cannot access such quotes, which are only available to broker-dealers. Accordingly, the Expert Market has extremely limited liquidity and we do not believe that the quotations on the Expert Market are reflective of the Company’s market value.
As previously noted, the Company is moving with all diligence to complete the reaudit, filing the necessary amended SEC reports and as soon as practicable, becoming current with its SEC reporting requirements. When it does, the Company’s common stock will be automatically restored to quotation on the OTC Pink Tier of the over-the-counter market and the Company will continue its efforts to complete an uplisting of its common stock.
It is important to note that the unfortunate consequences of the Borgers SEC sanctions in no way have adversely impacted the Company’s operations and growth as disclosed in its SEC reports and press releases. Moreover, as reported in a Form 8-K filing on August 22, 2024, two new independent directors have recently joined SSi’s board of directors – Dr. Frederic H. Moll, a pioneer executive in the surgical robotics field with 30 years of experience who founded and co-founded multiple surgical robotics companies, including Intuitive Surgical, Inc, a world leader in surgical robotics and Timothy P. Adams, a well-known and highly regarded healthcare executive with over 30 years of hospital operations experience.
AveragePenny
6月前
$SSII Meet The Latest Innovation In Robotic Surgery: The SSi Mantra-3
https://www.globenewswire.com/en/news-release/2024/07/18/2915387/0/en/Meet-The-Latest-Innovation-In-Robotic-Surgery-The-SSi-Mantra-3.html
FORT LAUDERDALE, Fla., July 18, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, today announced that its SSi Mantra-3 Surgical Robotic System (“SSi Mantra) will be unveiled in New York City next week in an exclusive demonstration for media, analysts and the investment community.
The SSi Mantra 3, which is the first unit of its kind that can feature up to 5 robotic arms, will be available for viewing and an actual trial demonstration will be conducted daily from Tuesday, July 23rd through Thursday, July 25th from 12:00-1:30 pm ET at SS Innovations’ newly opened showroom located in the New York City financial district. For those that cannot attend in person, a live stream webcast will also be offered on July 23rd which can be registered for here:
https://www.ssinnovations.com/exclusive
This event will offer a unique opportunity to witness the next generation, disruptive SSI Mantra 3 Surgical Robotic System in operation and the surgical innovations it offers.
Event Highlights:
Live demonstrations of the SSI Mantra 3 Surgical Robotic System
Insights into the future of surgical robotics and our innovative solutions
Networking opportunities with industry experts and the SS Innovations Senior Executive Team
Key Opinion Leaders such as Dr. Frederic Moll, Dr. Vipul Patel, Dr. Husam Balkhy, Experienced Robotic Surgeons, and our Executive Team will be available to discuss the impact of the new SSi Mantra 3 and field questions from participants.
AveragePenny
6月前
Recap: $SSII SSi Mantra Expands Global Footprint: Nepal's First Surgical Robot Set to Transform Healthcare Sector
https://www.globenewswire.com/en/news-release/2024/07/09/2910282/0/en/SSi-Mantra-Expands-Global-Footprint-Nepal-s-First-Surgical-Robot-Set-to-Transform-Healthcare-Sector.html
Baidya & Banskota (B&B) Hospital Installs Nepal's First Surgical Robotic System, India made SSi Mantra
SSi Mantra integrates cutting edge advancements in robotic surgery, offering surgeons unparalleled precision and control for improved patient outcomes
SS Innovations helps reinforce India's position as a global hub for technological innovation in healthcare
FORT LAUDERDALE, Fla., July 09, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, today announced that its SSi Mantra Surgical Robotic System (“SSi Mantra”) has been installed at Baidya & Banskota Hospital (“B&B Hospital”) in Kathmandu, Nepal marking the first time a surgical robotic system has been installed in Nepal. SSi Mantra’s cutting-edge technology underscores B&B Hospital’s commitment to delivering superior healthcare and helps position the institution at the forefront of medical innovation in the region.
The collaboration between SS Innovations and B&B Hospital represents a breakthrough in Nepalese healthcare. Under the leadership of Prof. Dr. Jagdish Lal Baidya, Dr. Niraj Lal Baidya and Dr. Saroj Lal Baidya, and support from Prof. Dr. Ashok Kumar Banskota B&B Hospital in Gwarko, Lalitpur has become the first hospital in Nepal to install this advanced surgical robotic system, which we believe will greatly benefit many patients across that country.
The SSi Mantra is known for its precision, minimally invasive capabilities and advanced technology, helping to ensure enhanced surgical outcomes and quicker recovery times for patients. By integrating this state-of-the-art system, B&B Hospital will be able to offer its surgical patients access to the highest standards of medical treatment.
Commenting on the installation of SSi Mantra in Nepal, President and COO of SS Innovations, Dr Vishwa Srivastava, said “We are extremely proud of being able to provide this much-needed technology to our Himalayan neighbours in the north. We have full faith that the excellent doctors at B&B Hospital will help elevate the level of care in Nepal. This placement is a powerful reminder of what inspired us to develop our SSi Mantra Surgical Robotic System and make it affordable and accessible for all.”
On the installation of the SSi Mantra robotic system in B&B Hospital, Prof. Dr. Jagdish Lal Baidya, Co-Founder of B&B Hospital, commented “We are thrilled to announce that B&B Hospital has become the first institution in Nepal to install the cutting-edge SSi Mantra robotic surgical system. This advanced technology will assist in performing several key specialty surgeries, greatly enhancing patient care. SSi Mantra's groundbreaking technology has the potential to transform the way we perform surgeries, significantly benefiting our patients with its minimally invasive approach and superior precision. At B&B Hospital, we are always working towards improving the techniques and technologies to make surgeries safe, minimally invasive, and cost-effective.”
On the installation of the SSi Mantra robotic system in B&B Hospital, Prof. Dr. Ashok K Banskota, Co-Founder of B&B Hospital, commented - “Very happy and momentous occasion in the history of the development of surgery in Nepal, and in particular of the services at B&B Hospital. Hopefully, many Nepali patients will now be able to avail of the expertise underlying the advantages provided by robotic surgery technology. Hearty congratulations to all who have worked tirelessly to make this service available for the first time in Nepal. It is a long-cherished dream now fulfilled for our leader in Surgery/ Urology, Prof. Dr Jagdish Lal Baidya! I have great hopes for the success of this venture.”
B&B Hospital and SS Innovations intend to collaborate with the goal of setting a new standard for healthcare in Nepal by providing patients with cutting-edge robotic surgical options. This collaboration underscores a shared vision of decentralizing excellence and making innovative medical solutions accessible to all, irrespective of socioeconomic and geographical barriers.
AveragePenny
2年前
$AVMR AVRA Medical Robotics, Inc. (OTC: AVMR) PROVIDES UPDATE ON MERGER
https://www.globenewswire.com/news-release/2022/12/14/2573830/0/en/AVRA-Medical-Robotics-Inc-OTC-AVMR-PROVIDES-UPDATE-ON-MERGER.html
ORLANDO, FL, Dec. 14, 2022 (GLOBE NEWSWIRE) -- AVRA Medical Robotics, Inc. (“AVRA” or “the Company”) (OTC: AVMR), a medical robotics software and artificial intelligence company announced that it is continuing to progress to consummation of its acquisition by merger of CardioVentures, Inc. (“CardioVentures”), as previously reported in its Current Report on Form 8-K filed with the SEC on November 7, 2022.
CardioVentures holds an indirect controlling interest in an Indian private limited company (“SSI-India”). SSI-India is engaged in the development, commercialization, manufacturing, and sale of medical and surgical robotic systems utilizing patents, trademarks and other intellectual property. It has received full clinical approval by the Indian regulatory bodies and is now able to accept and deliver orders for its Mantra surgical robotic system within India and in over 54 other countries. With what the Company believes are superior functionality and ergonomics, the Mantra 2 can cost up to one half less than its direct competitors’ systems. Initial deliveries started in August 2022 in Delhi at the Rajiv Gandhi Cancer Institute and Research Center and the Mantra 2 System is now operating in 3 hospitals. SSI-India plans to begin seeking US FDA and European CE regulatory approvals in early 2023. The Mantra 2 System is a soft tissue based surgical robotic system, which the Company believes has broad applications in Urology, Gynecology, Thoracic, Head, Neck and General Surgery. Moreover, we anticipate that the system will be the first of its kind to be specifically tailored to assist in the performance of all complex cardiac surgical procedures.
Upon consummation of the merger, the Company will change its name to SS Innovations International, Inc. and the stockholders of CardioVentures will become the controlling shareholders of the Company. Post – Merger, we intend to focus a significant part of our efforts on expanding and further developing the business of SSI-India, which will be an indirect majority-owned subsidiary of the Company.
AveragePenny
2年前
$AVMR AVRA Medical Robotics, Inc. (OTC: AVMR) Becomes Current in its SEC Filing Status
https://www.globenewswire.com/news-release/2022/12/01/2566310/0/en/AVRA-Medical-Robotics-Inc-OTC-AVMR-Becomes-Current-in-its-SEC-Filing-Status.html
ORLANDO, FL, Dec. 01, 2022 (GLOBE NEWSWIRE) -- AVRA Medical Robotics, Inc. (“AVRA” or “the Company”) (OTC: AVMR) today announced that as of November 30, 2022, it has filed all required periodic reports with the Securities and Exchange Commission and accordingly is current in its filing SEC status.
The Company is progressing to consummation of its acquisition by merger of CardioVentures, Inc, as previously reported in its Current Report on Form 8-K filed with the SEC on November 7, 2022. CardioVentures holds an indirect controlling interest in Sudhir Srivastava Innovations Pvt. Ltd., an Indian private limited company (“SSI - India”). Based in Haryana, India. SSI-India is engaged in the development, commercialization, manufacturing and sale of medical and surgical robotic systems utilizing patents, trademarks and other intellectual property held by Dr. Sudhir Srivastava (the “SSI Intellectual Property”).
Upon consummation of the merger, the Company (which will change its name to SS Innovations International, Inc.), will acquire an indirect controlling interest in SSI India and ownership of the SSI Intellectual Property and Dr. Srivastava will become the Company’s controlling shareholder.
nehadesh
2年前
Wearable Medical Devices
The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.
The healthcare and wellness industry is shifting toward regulated, personalized, and monitored healthcare. In a short period, mobile devices have skyrocketed in use. With these advancements, wearable devices such as - well-being tools, health monitors, fitness devices, and disease prevention devices are becoming more vital in the healthcare field.
Today, artificial intelligence, robots, sensors, big data, radar technologies, IoT, and digital wearables can manage and prevent diseases. They can estimate blood pressure, body temperature, heart rate, and respiration and indicate risks such as declining health, worsening sickness, and other threatening situations like - increased blood pressure or breathing problems.
We have an experienced team of people who help companies /medical device manufacturers in streamlining their pathways for market approval. We have expertise in FDA & EUMDR regulatory compliance and also put efforts into error free deliverables. Feel free to contact us for any Wearable medical device regulatory assistance.
How can wearable devices improve health?
The last five years have seen an increase in digital wellness wearables that can collect data in real time and reveal the physical and chemical properties of the body to evaluate wellness. Wearables are small electronic devices that, when placed on your body, can help measure temperature, blood pressure, blood oxygen, breathing rate, sound, GPS location, elevation, physical movement, changes in direction, and the electrical activity of the heart, muscles, brain, and skin.
How is Wearable Technology used in Healthcare Nowadays?
Tracking Health Status
With a health monitoring device, doctors can track and measure their patient's vitals in real-time such as heart rate, ECG, blood pressure, body temperature, etc.; the gadgets can transmit the necessary patients' data to the doctors for further examination.
Therapeutic Treatment
Patients with chronic diseases can get timely treatment once their metrics exceed the level, e.g. getting automated insulin pumps or medications. Moreover, with these devices, doctors can better adjust the patients' therapy by monitoring their patients' conditions.
Health and Activity Tracking
Apart from doctors monitoring their patients' states, wearable gadget users can track their health status and follow a healthy lifestyle. This includes sleep pattern tracking, heart rate monitoring, blood oxygen concentration or SpO2 monitoring, calorie tracking, steps, swimming tracking, etc. In case of any irregularities, they can seek consultation from a qualified doctor to take preventative action against any disease development.
Other Uses
Wearables can also help in the diagnosis, screening, and monitoring of psychological disorders like depression. It also improves patient management efficiency in hospitals. In addition, wireless transmission in wearable systems allows researchers to develop new types of point-of-care diagnostic tools.
Top 5 Wearable Devices in Healthcare
Wearable Fitness Trackers
Some of the simplest and most original forms of wearable technology, wearable fitness trackers, are devices equipped with sensors to keep track of physical activity, heart rate, oxygen level, blood pressure, etc. These provide wearers with health and fitness guidance by syncing to various smartphone apps. Wearers can get a good idea of how healthy they are. Few wearable fitness monitors support the setting of daily fitness goals and show the progress made on those goals.
Smart Health Watches
Smartwatches allow users to perform tasks they normally do on their phones - read notifications, send simple messages, and make phone calls, while also offering some of the exercise and health-tracking benefits of fitness trackers. A smartwatch sends you a notification that you need to do more exercises, or it can alarm you if you're exerting too much effort. Having a smartwatch that can effectively monitor your heart rate is a great way to avoid injuring yourself.
Wearable ECG Monitors
Wearable ECG monitors are on the cutting edge of consumer electronics, and what sets these monitors apart from some smartwatches, is their ability to measure electrocardiograms or ECGs. Some personal-use ECG devices have built-in screens so you can see your heart rhythm on the monitor. Other devices connect to a smartphone or computer application where you can record, view, store, and share your ECG readings.
Wearable Blood Pressure Monitors
Wearable blood pressure monitors are devices that you wear and that can easily and quickly measure the levels of your blood pressure. We are all used to those traditional devices that you can use now and then remove from your hand until you decide to use them once again, but things are changing in this industry, and people are coming up with all kinds of possible solutions. Well, this particular product is one of those possible and better solutions, since you have the opportunity to check your blood pressure wherever you are and without any trouble. All you need to do is have a device on your wrist that can do the measurement for you.
Wearable biosensors
Wearable biosensors are portable electronic devices that enable real-time monitoring and feedback to the user on various biological and physiological indicators. They can provide real-time measurements of various biological parameters, including blood pressure, heart rate, temperature, respiratory rate, and activity levels. They create two-way feedback between the user and their doctor and enable continuous and noninvasive disease diagnosis and health monitoring from physical motion and biofluids.
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nehadesh
2年前
UKCA marking for medical devices
UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.
manufacturers now need to plan for how they will obtain a UK Conformity Assessment mark before 30th June 2023. As many have seen, there have been delays in obtaining the mark, so the quicker manufacturers act, the better.
Operon strategist is medical devices consulting has a good experience in consultation and regulatory expertise for manufacturers and suppliers of medical devices. for any medical device registration process, UKCA marking and licensing you can connect with us.
WHAT ARE THE REQUIREMENTS FOR CE MARKED PRODUCTS IN THE UK?
From 1 January 2021, there are a number of requirements that products marketed as medical devices in Great Britain (England, Wales and Scotland) must comply with:
Certificates issued by notified bodies recognised by the EU will remain valid for the UK market until 30 June 2023.
The EU no longer recognises the UK’s notified bodies.
UK Notified Bodies cannot issue CE certificates (except for the purposes of the “CE UKNI” mark, which is valid in Northern Ireland), and have become UK Approved Bodies.
A new route to market and product marking is available for manufacturers wishing to obtain UKCA marking for medical devices.
From 1 January 2021, all medical devices, including in vitro diagnostic (IVD) medical devices, marketed in Great Britain must be registered with the MHRA. There is a grace period for registration:
Class III and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered by 1 May 2021.
Other Class IIb devices and all Class IIa devices and Schedule B IVD products and self-testing IVDs must be registered from 1 September 2021.
Class I devices, custom-made devices and general IVDs must be registered from 1 January 2022
Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with authorised representatives based in Northern Ireland) must continue to register their devices from 1 January 2021.
So what is the difference between what you have to do to place a CE Mark on a product versus a UKCA Mark?
There are two levels to this answer:
The mechanics of UKCA-marking
The regulatory basis for conformity assessment
The mechanics are that a UK Approved Body will need to perform the conformity assessments that formerly the EU Notified Body (NB) would do. It appears that the two UK-based NBs that are able to do the necessary for medical imaging products will become UK Approved Bodies automatically, so not much change there, except that they will need to authorise both a CE mark and (in due course) a UKCA mark (likely at an extra fee). It is not clear whether EU-based Notified Bodies will be allowed, and at what point in time, register as UK Approved Bodies.
Additionally, while the UK standards will be the same in substance and with the same reference as the standards used in the EU, they will use the prefix ‘BS’ to indicate that they are standards adopted by the British Standards Institution as the UK’s national standards body. All references to standards in any regulatory documentation to be submitted for a UKCA assessment would therefore have to be updated with the ‘BS’ prefix.
For Class I & general IVD:
Class I device or general IVD do not third-party conformity assessment. Class, I device manufacturers must self-declare that the device meets the UK MDR criteria. If a class I device has any sterile or measuring functions, the manufacturer needs to approach the UK-approved body for the conformity assessment.
For Class IIa, Class IIb, Class III, IVD:
For Class IIa, Class IIb, Class III, IVD medical devices involvement of a UK-approved body is necessary to undergo a conformity assessment procedure. After approval from a UK-approved body, a manufacturer can declare that devices conform with the UK MDR 2002 and place it on the market.
All class medical device manufacturers must sign a ‘declaration of conformity before placing the UKCA marking on their product. The manufacturer needs to include the name of the UK-approved body if it is involved.
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FDA 510k Clearance process consulting
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nehadesh
2年前
What Does a FDA 510( k) Clearance mean?
Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product must meet criteria for the same intended use, have the same technology or( slightly) different technology but produces similar end results, and be safe and effective.1 Once “pre-market clearance ” is took from the FDA the device can be distributed commercially immediately.
There are important differences between “ cleared ” and “ approved ”. When a medical device is cleared, this means it has experienced a 510( k) submission, which FDA has reviewed and handed clearance. For Class III medical devices to be legally marketed they must suffer a rigorous review and approval process orpre-market approval( PMA).
In the United States, this frequently means submitting a 510( k). A 510( k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration( FDA) for “ clearance ” before you can deal your device in the U.S. In order to receive clearance from the FDA, your 510( k) will need to demonstrate that your medical device is substantially equivalent to another legally marketed device (called a predicate device).
What Exactly is Substantial Equivalence?
Now that we know what a 510( k) is, let’s talk about the substantial equivalence standard. You ’ll recall from the intro that your 510( k) must show that the new( or modified) device is substantially equivalent to at least one other legally marketed device, called a predicate device. Substantial equivalence looks at the intended use and the technological characteristics of the two devices.
Operon Strategist is a leading medical device consultant providing FDA 510k Clearance process consulting to the customers to register SBU( Small Business Unit), if applicable. Take out the testing demand of the product, creation of the dossier, resolving the queries and after completion of all the conditioning, the customer receives the US FDA 510 k premarket approval. We also help with the establishment enrollment and device listings to make suitable the supply of medical devices in the US.
We helps during the process of submitting operations for class I, II, III medical devices at any stages of the product development. Our team of good experts will successfully prepare and submit FDA medical device regulatory documents for theU.S and international customers. These operations include
510( k) Premarket Notifications
Premarket Approval Applications( PMAs)
De Novo Request( Application)
513( g) Requests for Classification
Investigational Device Exemption Applications( IDEs
Investigational New Drug Applications( INDs)
510( k) Premarket Notifications
Operon Strategist provides answers to related questions
Which groups( Class I, II, and III) do we require an FDA 510( k)?
How many stages consist of the 510( k) application process?
A class I, II, and III device intended for human use, for which a Premarket Approval FDA operation( PMA) isn't needed, must submit a 510( k) to FDA unless the device is pure from 510( k) conditions of the Federal Food, Drug, and Cosmetic Act( the FD&C Act) and doesn't exceed the limitations of exemptions in.9 of the device classification regulation chapters(e.g., 21 CFR862.9, 21 CFR864.9). Technically, under the 510( k) process, the FDA doesn't “ authorize ” medical devices and IVDs; the FDA issues a “ clearance ” or “ Approval ” for deal in the United States. typically, the FDA shall be subject to a provision of 510( k), should manufacturers intend to deal the Class II Medical Devices and some needed Class I and III bias or IVDs on the US market. Apre-market 510( k) approval is also required for already approved medical devices( Predicate) if the manufacturer( s) modifies the technology or changed the intent of device operation in a way that significantly affects patient safety or device performance.
The 510( k) is generally the most effective route to market clearance in the U.S. because you show your device is safe and effective based on this substantial equivalence standard, rather of demanding to present more expansive clinical trial data.
There are three types of 510( k) Traditional, shortened, and Special. This eBook will begin with a general overview of the 510( k) process, including its purpose and benefits. Next, we will explore the Traditional 510( k) and the sections and factors needed in depth. Finally, we will look at the Special and shortened 510( k).
When is a 510( k) needed?
A 510( k) is needed for medium risk devices that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the new device. Meanwhile, a PMA is needed for high- risk or new devices which bear a advanced position of scrutiny to be verified safe and effective.
Complaints
Still, the end user can file a complaint with the FDA or the manufacturer, If a FDA 510( k) cleared medical device isn't performing as intended.
The user or client can also file a complaint with the FDA if it knows that the manufacturer or his representative or distributor is making false marketing claims or incorrectly promoting the performance of their device. This is a straightforward process to insure that medical devices on the market are being held to strict standards to make sure it's being used safely and effectively
Things to Consider
Before choosing a product with a FDA 510( k) clearance, it's important to understand what the product is claiming to do. Similar products may not perform exactly the same due to differences in technology or manufacturing. It's also important to make sure to read the indications for use to know how to use the product properly. Eventually, test data that has been transferred to the FDA should be available to the end user, frequently in a confirmation guide or test report.
Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.
nehadesh
2年前
The US Food and Drug Administration has published a largely anticipated proposed rule to harmonize its medical device quality management system( QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard.
FDA’s proposed rule “ would harmonize quality management system conditions for FDA- regulated devices with conditions used by numerous other regulatory authorities around the world, ” the agency countries. Greater alignment of FDA Quality System Regulation( QSR) with ISO 13485, first proposed by the regulator in May 2018, would bring US QMS conditions for medical device manufacturers closer in line with quality system conditions in markets similar as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the US and other markets.
What's ISO 13485 Quality Management System
How do you manage your Quality Management System? If you're like the majority of the medical device industry, chances are you have a QMS that's a combination of paper- based processes and general purpose tools, approximately held together by a group of people within your company-- generally document control.
It’s important because it's long overdue with the former interpretation being released 13 years before in 2003.
The 2016 standard is veritably much a bridge. What I mean is that this bridge explicitly describes and defines current QMS prospects for medical device companies. Prior to these advances being formally defined and documented in the standard, numerous of the best practices being advised and adopted were veritably ad hoc in nature and frequently sounded to be based on auditor opinions.
Medical device manufacturer should appoint an experienced ISO13485 consultant who can work on all risk class devices. The associations need to cover the safety and risk information during product life cycle as per ISO 13485 demand. As an ISO 13485 medical device consultant, Operon Strategist identify the specific regulatory demand for the product similar as MDR, FDA 510( k) during the perpetration. This helps manufacturer in the further process of CE mark medical device or FDA 510( k) clearance.
An Overview of the ISO 13485 Quality Manual for Life Sciences
The International Organization for Standardization( ISO) is an internal standard- setting group of representatives from public standards associations.
This group maintains a comprehensive set of standards for life sciences associations. These standards are generally referred to as ISO 13485 standards. The current version of ISO 13485( last streamlined in 2020) sets forth major manufacturing and quality guidelines for businesses in largely regulated industries.
To alleviate unforeseen danger and uphold universal quality control standards across the medical device manufacturing industry, an ISO 13485 quality homemade outlines the mission-critical quality control guidelines and QMS conditions needed to keep both users and manufacturers safe.
ISO 13485 Documentation Requirements
By now, you should be veritably familiar with the word “. still, also it did n’t be, if it is n’t proved. ”
Yes, documentation of QMS processes, quality events, and workflows is critically important. occasionally the notion of documentation can produce angst within a company. occasionally the idea of documentation is viewed as overly burdensome and frequently times unnecessary with little value added.
In my experience, utmost companies do produce quite a many burdens and obstacles regarding documentation. And it does n’t have to be this way.
Documentation should be about defining processes and maintaining the records needed to demonstrate these processes are being followed. Documentation is crucial for objective substantiation. Objective substantiation to support your employees through design, development, manufacturing, and support of medical devices. Objective substantiation to demonstrate that conditions are being addressed.
Establishing thorough, yet functional, document operation practices for your business is one of the most important foundational rudiments of a QMS.
Benefits of an ISO 13485 Quality Manual
A comprehensive ISO 13485 quality homemade serves as the nautical design for workers, guests, controllers, and others that come in contact with your life lores incipiency or scale- up. also, an up- to- date ISO 13485 quality homemade ensures that your association’s QMS noway falls below norms.
Another benefit of the ISO 13485 primer is the pledge of increased customer confidence. Some guests will not indeed ask to see further bribes if they've evidence of an active ISO instrument and access to a quality primer. From an functional viewpoint, taking the time to collect this collection of attestation is well worth the time and trouble.
Key elements of an ISO 13485 Quality Policy:
Adapt the policy to the association.
Define a frame for setting your quality objects.
Establish the commitment to meeting all conditions.
Establish the operation commitment.
Communicate the Quality Policy.
insure the regular review of the Quality Policy.
What's the ISO 13485 Quality Policy?
The Quality Policy should be the overall thing of the association, and is written by top operation in order to direct everyone in the association as to how medical devices will be created and delivered to the guests.
This top- position policy is intended to be communicated and understood by everyone in the company, so they can all follow one strategic direction on how product development happens and how conditions will be met. Commitment to quality can also be used throughout the association as a focus on how processes are performed, and as a companion for the quality objects of the association — those main enhancement aims that the company plans to achieve.
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AveragePenny
3年前
$AVMR AVRA Medical Robotics, Inc. Appoints Dr Doga Demirel to its Surgical Robotic System Team
https://www.globenewswire.com/news-release/2021/12/21/2356170/0/en/AVRA-Medical-Robotics-Inc-Appoints-Dr-Doga-Demirel-to-its-Surgical-Robotic-System-Team.html
ORLANDO, FL, Dec. 21, 2021 (GLOBE NEWSWIRE) -- AVRA Medical Robotics, Inc. (“AVRA” or “the Company”) (OTC: AVMR) today announces the appointment of Dr. Doga Demirel, a leading expert in computer science, particularly as it applies to surgical procedures ranging from airways through the minimization of invasive procedures for joints and bones, to pancreatic cancer, as Senior Design Scientist to join the AVRA team and assist in the development of its advanced surgical robotic system.
Dr. Demirel joins AVRA from Florida Polytechnic University, where he is an Assistant Professor in Computer Science and the Assistant Chair of Computer Science. His areas of focus include Virtual Surgical Design and Development, Virtual Reality, Haptic Applications and Technology, Medical Simulations and Visualization.
Barry Cohen, AVRA Chairman & CEO, explaining the significance of the appointment, said: “Dr Demirel’s leading-edge published work focused on imaging and graphics and on the use of computer controls for several different types of procedures should enable us to further develop and expand the capabilities and our surgical robotic system will be able to perform beyond those we’ve already been developing.”
Dr. Demirel added: “I look forward to assisting the AVRA team in developing a sophisticated combination of imaging, targeting, guidance and intelligence to assist surgeons performing aesthetics and other skin resurfacing procedures.”
The Company is continuing to work with its accountants and auditors to become current in its periodic report filings with the SEC.
For further information about AVRA Medical Robotics, visit http://www.avramedicalrobotics.com or contact the company at info@avramedical.com
AveragePenny
4年前
$AVMR AVRA Medical Robotics, Inc. Appoints Dr. Onur Toker to Accelerate Development of its Surgical Robotic System
https://www.globenewswire.com/news-release/2021/06/28/2254158/0/en/AVRA-Medical-Robotics-Inc-Appoints-Dr-Onur-Toker-to-Accelerate-Development-of-its-Surgical-Robotic-System.html
Orlando, Florida, June 28, 2021 (GLOBE NEWSWIRE) -- AVRA Medical Robotics, Inc. (“AVRA” or “the Company”) (OTC Pink: AVMR) today announces the appointment of Dr. Onur Toker, a leading expert in electrical and computer engineering, as Senior Design Engineer to accelerate the development of its advanced surgical robotic system.
Dr. Toker joins AVRA from Florida Poly, where he is an associate professor in electrical and computer engineering focusing on hardware acceleration, field-programmable gate arrays (FPGA), embedded systems, tele-robotics, and sensors.
Explaining the significance of the appointment, Barry Cohen, AVRA Chairman & CEO, said: “Dr Toker’s leading-edge published work on Delay Sensitive Tele-robotics, the design of fiber optic sensors and image processing pressure sensors will give us a tremendous boost in the development of our surgical robotic system. With Dr Toker’s help, we should be able to speed up the delivery of the most sophisticated combination of imaging, guidance, targeting and intelligence to assist surgeons performing aesthetics and other skin resurfacing procedures.”
Dr. Toker added: “AVRA’s surgical intelligence software is being developed to enable surgeons to deliver a level of accuracy, precision and reproducibility never before seen, by enhancing a surgeon’s fine motor skills with the ability of a surgical robot to perform delicate tasks with absolute precision and my work in these areas should allow us to produce an even more sophisticated model far quicker than the original plans allowed”.
As Barry Cohen summed up: “Dr Toker will be using his knowledge and skill to help us deliver a prototype of our next-generation aesthetics robot surgeon in time for the prestigious 13th 5CC World Congress in Barcelona this September 2021.”
The Company continues to work with its new independent public accounting firm to become current in its SEC periodic reports in the near future.
For further information about AVRA Medical Robotics, visit http://www.avramedicalrobotics.com or contact the company at info@avramedical.com
deri21
5年前
$AVMR AVRA Medical Robotics (OTC: AVMR) CEO Barry Cohen Acquires 1,000,000 Shares of Company Stock.
AVRA Medical Robotics, Inc. (the “Company”) (OTCQB: AVMR), an artificial intelligence company building a fully autonomous medical robotic system combining artificial intelligence, machine learning and proprietary software, today announces that its Chairman & CEO, Barry Cohen, has increased his stake in the company by approximately 5% by purchasing an additional 1,000,000 common shares of AVRA stock. The shares will be restricted.
AVRA CEO Barry Cohen purchased his 1,000,000 shares by simultaneously exercising his option to purchase the shares at an exercise price of $0.10 per share, which put another $100,000 onto the Company’s balance sheet, while further reducing the company’s debt with a ‘debt for equity swap’ which canceled a $100,000 loan note he had granted to the Company.
This follows the Company’s recent announcement that, with the exception of loans from the CEO and a loan note for $25,000 due December 31, 2020, the Company had cleared all of its outstanding external debt, with one note of $25,000 being converted into shares at $1.50 per share and the remainder being repaid in full with accrued interest. Mr. Cohen now owns 10,536,438 common shares.
Mr Cohen commented, “While the extreme effects of the spread of the Coronavirus continue to disrupt our society and economy, the fundamentals of our Company and the opportunity to use medical technology like ours to improve people’s quality of life is more evident than ever. I believe the current stock price does not reflect AVRA’s growth potential, which is why I continue to invest even more of my personal funds in the company.”
deri21
5年前
$AVMR AVRA Medical Robotics, Inc. (the “Company”) (OTCQB: AVMR), a medical software and artificial intelligence company building a fully autonomous medical robotic system combining artificial intelligence, machine learning and proprietary software, today announces that it has paid off almost all of its external corporate debt, including accrued interest.
With the exception of loans from the CEO and a loan note for $25,000 due December 31, 2020, the Company has now cleared all its outstanding external debt, with one note of $25,000 being converted into shares at $1.50 per share and the remainder being repaid in full with accrued interest.
Mr Cohen, AVRA CEO, said, “The repayment of all this Company debt provides further stability to the company’s finances, allowing us to focus on our medical software procedure program and the development of our Autonomous Robotics Surgical System. The potential of our robotic systems is to perform operations with greater precision than human hands are capable of.”
Contacts: Barry Cohen
AVRA Medical Robotics, Inc.
Chairman and CEO
bcohen@avramedical.com
deri21
5年前
$AVMR AVRA Medical Robotics Appoints Two World Renowned Professionals to Chair its Medical and Scientific Advisory Boards
ORLANDO, Fla., Sept. 20, 2019 (GLOBE NEWSWIRE) -- AVRA Medical Robotics, Inc. (the “Company”) (OTCQB: AVMR), an emerging company which is building a fully autonomous medical robotic system through the use of new technologies combining artificial intelligence, machine learning and proprietary software, announced today it has appointed Dr. Vipul Patel to Chair its Medical Advisory Board and Dr. Eytan Pollak to Chair the Scientific Advisory Board, effective immediately.
Barry F. Cohen, Chairman and Chief Executive Officer of the Company, commented, “I am extremely pleased to have these two distinguished doctors join the AVRA team. Dr. Patel and Dr. Pollak are both world renowned figures in their respective industries – Dr. Patel is one of the most robotic-experienced medical professionals in the world and Dr. Pollak is one of the most highly regarded scientists with a deep knowledge and expertise in control systems, robotics and simulation, as well as artificial intelligence applications. I believe Dr. Patel and Dr. Pollak will bring a plethora of knowledge and experience to assist AVRA in our mission of commercializing a fully autonomous medical robotic system.”
Dr. Vipul Patel is the founder and Medical Director of the Florida Hospital Global Robotics Institute, founder and Vice President of the Society of Robotic Surgery, and founder and Editor Emeritus of The Journal of Robotic Surgery. He is board certified by the American Urological Association and specializes in robotic surgery using the da Vinci Surgical System for prostate cancer. As of February 2018, he performed his 11,000th robotic-assisted prostatectomy and is now nearing his 13,000th procedure. The large volume of prostatectomies he has performed has enabled him to amass a large amount of statistical evidence regarding the efficacy of robotic techniques which has been used in developing and refining techniques. Patel credits the use of robotic assisted surgery with helping surgeons achieve better surgical outcomes with the "trifecta" of cancer control, continence and sexual function. In the course of his career, Dr. Patel has led and participated in studies that have resulted in developing improved outcomes for robotic surgery and urologic treatments.
Dr. Eytan Pollak received his B.Sc. and M.Sc. from Technion-I.I.T. (Haifa, Israel) and his Ph.D. from Purdue University, West Lafayette, Indiana. He has 30 years of experience in managing research and development programs, holds several patents, and has published papers in Control Systems, Robotics, Distributed Flight and Ground Simulations/Simulators, Embedded Systems, and Cyber Physical Systems. He served as an M&S Technology Manager, IRAD Technical Director and Principal Investigator at Lockheed Martin. He is currently a research professor at the UCF School of Electrical Engineering and Computer Science, and he is also the Director of Strategic Technologies at L3Harris Technologies Communications Link Simulation & Training.
About AVRA Medical Robotics
AVRA Medical Robotics, Inc., (OTCQB: AVMR) is modernizing the practice of surgery by developing a fully autonomous medical robotic system that “robotizes” a wide range of medical procedures currently being performed by human hands using surgical and non-surgical devices and instruments. AVRA is concentrating its research and development efforts to meet rising expectations of patients and practitioners alike for the precision, efficiencies and safety offered by robotics, artificial intelligence and proprietary software when combined with proven medical devices and surgical instruments. AVRA’s current focus is developing a treatment-independent precision guidance system, applicable to a variety of minimally and non-invasive procedures, to leverage the growing demand for practical medical robotic devices, with an initial focus on skin resurfacing aesthetic procedures.
For more information visit the company’s website at www.avramedical.com.
deri21
6年前
AVRA Medical Robotics, Inc. issues CEO letter to ShareholdersPress Release | 02/05/2019
ORLANDO, Fla., Feb. 05, 2019 (GLOBE NEWSWIRE) -- Avra Medical Robotics, Inc. (OTCQB: AVMR) issues the following letter to Shareholders from the CEO:
Dear Shareholder,
Over 95% of you have been with the AVRA TEAM and me for more than six years. You have been patient, supportive and well-wishing during these past years. Our most recent investors have been with AVRA for two years now and have supplied important help carrying our Mission to fruition. We have seen AVRA Medical achieve several milestones - creating teams of medical, engineering, software, management personnel; producing a prototype and entering the financial markets as a public company, which we believe will open the company’s ownership to many new investors.
Part of our strategic plan at AVRA was to provide a vehicle for individual investors to come into the firm at a low price usually available only to Private Equity, Institutional and High Stakes investors in this high-profile business, complete with a complex mix of Science, Math, Physics, Medicine, Surgery, Engineering all bound together by Hardware and Software talents. Therefore, I am especially proud of our TEAM of Executives, Medical Advisory Board (MAB) Members and our Scientific Advisory Board Members. If you take a close look at the profiles of these people who help guide your company you will find the most accomplished achievers in their specialties in robotic surgery, including the surgeons who did the FIRST and the MOST prostate surgeries and the surgeon who works on the TINIEST Patients (infants under three weeks) with a medical robot. Add to that impressive list our noted Robotic Oncologist, Cardiologist, Plastic Surgeon, Urologist and Imaging experts to round out our expert MAB.
Members of our Scientific Advisory Board similarly have excellent credentials, which match those of their colleagues on the MAB, demonstrating high achievements in scientific fields, including Dermatology, and Software Design. Our team includes a Dermatologist that led the Dermatology Department at Sloan Kettering, a Biochemist known for his developments in Science, Medicine and Insurance, and a Systems Engineer with a Technical and Software background that includes positions at Lockheed Martin, GE Engineering and Boeing. All are important members of the AVRA TEAM. I’d encourage you to learn more about our amazing team by accessing our website at: https://www.avramedicalrobotics.com/who-we-are/.
The company also enjoys the Special Advisory consultation of Mr. Tony Nicholson of the Nicholson Surgical Robotic Training Center in Celebration, Florida, Mr. Thomas Grace, a career Financial Markets executive, and Mr. Jack Pechter, a career Land Developer and Philanthropist with leanings to Medical Care.
We are also pleased to have entered into a four-year agreement with regulatory and compliance consultant Timothy K. Duggins. Tim is an award-winning regulatory expert with 30+ years of international experience in obtaining market access approvals for medical products. Through his assistance, AVRA is now an FDA registered company.
AVRA has expanded its research and development engagement with the University of Central Florida. Andrea Adkins, Assistant Director in UCF’s Office of Technology Transfer, began a 9-month sabbatical at AVRA, assisting with intellectual property, licensing and product development.
It is no wonder it took 17 years for Intuitive Surgical Corp. to finally see another Medical Robotic soft tissue competitor enter the Robotics field and take aim at breaking its Monopoly. It is also a special message for our shareholders to know that the Founder of Intuitive Surgical (ISRG) is also of member of the AVRA Shareholder Family through his new privately-held Medical Robotics firm.
We at AVRA are pleased to advise our Shareholder Family that our shares of common stock are listed for trading under the symbol AVMR on the OTCQB tier of the over-the counter market operated by OTC Markets Group, Inc. As we are a development stage company which has just entered the Financial Markets, you may find that when depositing shares into your brokerage account, you may be subject to additional review by your brokerage firm. AVRA will be pleased to assist you in answering any questions you may encounter in this regard and can also direct you to brokerage firms who are more familiar with AVRA and accordingly may facilitate your ability to deposit your shares.
We further remind you that AVRA files quarterly, annual and other periodic reports with the SEC. You may access all such filings through the SEC’s website at www.sec.gov.
Our Laboratory, Software Design Studio and Machine Tool facilities, as well as our executive offices are located at our Corporate headquarters in the Central Florida Research Park adjacent to the University of Central Florida in Orlando. Shareholders are welcome to visit by appointment.
Medical Robotics is still in its infancy and we believe that AVRA is well positioned to lead in Automation, Advanced Science, Artificial Intelligence (AI) and Software Design to bring robotic surgery to various procedures now being done only by hand or by the mechanically manipulated devices, which currently are often referred to as Robots. But know this...you are the owner of shares in a company that uses a REAL ROBOT (automation) and our mission is to bring computerized excellence and economy to surgery to benefit the ultimate subject…THE PATIENT.
We are proceeding with our first mission to implement our Robotic System in Dermatological Surgery, after which we plan to ROBOTIZE other FDA APPROVED Hand-Held instruments to improve patient outcomes in other areas of surgery and treatment. The AVRA System, which aims to provide practicing surgeons in various surgical fields with specialized software programs with which to simulate the procedure, observe its outcome prior to doing it, make any adjustments, and only then program the AVRA SYSTEM with its Intelligent Guidance System (IGS) to commence the procedure.
This Mission of bringing AVRA to this point has been the most interesting and fulfilling activity of my long business career. It has been a privilege for me to have had your support in this endeavor.
As we embark on our journey opening the doorway of AVRA to new shareholders I just wanted to share this message to our small family and thank all of you, for always just being there for the A TEAM.
Best regards,
/s/ Barry F. Cohen
Chairman & CEO
AVRA Medical Robotics, Inc.
info@avramedical.com
About AVRA Medical Robotics, Inc.
AVRA Medical Robotics, Inc., ("AVRA") is a surgical digital technology company whose primary goal is to provide surgeons with the ability to achieve consistently excellent results for the patient. AVRA is developing an intelligent medical robotic system for skin resurfacing procedures in partnership with the University of Central Florida ("UCF"). AVRA was organized by a senior leadership team with broad and deep experience in medical research, artificial intelligence, innovation and development in the medical robotics field. AVRA is concentrating on the growing demand for practical medical robotic devices by developing a platform-independent precision guidance system, applicable to a variety of minimally invasive and non-invasive procedures, with an initial focus on skin resurfacing. Employing advanced technology, AVRA is combining attributes of imaging with target acquisition and guidance. The skill and experience of its leadership team is enhanced by the active participation in development of UCF, which is recognized particularly for its work in the area of medical robotics research and design. Moreover, AVRA's leadership team is also experienced in marketing, chain management, and the implementation of all other aspects of business operations. These advanced, semi/autonomous systems will have boundless diagnostic and therapeutic applications - Target, Diagnose, Treat.
For more information, please visit www.avramedical.com.
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