conix
3年前
Marietta’s MiMedx moving past recent woes
By Andy Peters, The Atlanta Journal-Constitution
High hopes for a new arthritis drug
Marietta skin graft maker MiMedx hopes a treatment it is developing for osteoarthritis, tendonitis and plantar fasciitis will help it bounce back from a scandal that saw its former CEO go to prison for securities fraud last year.
The company plans to start late-stage trials by December of its injection therapy for musculoskeletal conditions. If federal regulators approve the drug, MiMedx could begin selling it as soon as the second half of 2026 and help return the company to its high-flying days.
“It’s a huge, huge market,” CEO Tim Wright said during a recent interview at MiMedx headquarters. “At least 240 million patients suffer from knee and hip osteoarthritis worldwide.”
Ramakanth Swayampakula, an analyst for investment bank H.C. Wainwright & Co., wrote in a November report that MiMedx, with its revamped management, a multiyear commercialization plan and a late-stage research and development pipeline, should see significant sales growth in the coming years.
The new treatment is made from placental tissue that has been ground into a powder, added to a liquid solution and injected at the source of osteoarthritis. The anti-inflammatory and healing properties of the mixture promote rapid regeneration of vital cells.
The chemical makeup of placental tissue can’t be replicated synthetically. MiMedx obtains the tissue from women who have recently given birth through cesarean section and have donated their placentas.
Other pharmaceutical companies are testing similar injection treatments, though none has obtained U.S. Food and Drug Administration approval.
In the meantime, MiMedx will continue to rely on its line of skin substitutes made from placental tissue that are used to treat diabetic foot ulcers, burn unit patients and other severe wounds. The skin grafts, which are produced in sheets, keep wounds sterile and promote healing.
Its sales of wound-care products rose 15% in 2021 to $240 million, compared to 2020. But that is lower than the company’s 2018 peak of $359 million, according to regulatory filings.
Wright, who joined MiMedx as CEO in May 2019 after a stint at Teva Pharmaceuticals, said the company wants to expand wound-care product sales to surgical recovery units and launch sales in Japan.
The global wound-care market is huge, with market research firm DelveInsight estimating its value could grow 80% from its 2020 figure of $9.5 billion to $17 billion in 2026.
Wright said he expects Veterans Administration hospitals to provide a major sales boost for MiMedx, as its wound-care products are “tailor-made for our active military members and our veterans.” MiMedx recently won a $67 million contract with the U.S. Department of Veterans Affairs.
MiMedx’s sales to the VA hospital system were at the center of a years-long criminal investigation. In 2020, the company paid $6.5 million to settle a federal probe into overcharging the VA.
As part of that probe, former CEO Pete Petit was accused of masterminding a scheme aimed at inflating revenues at the company. He was convicted of securities fraud in February 2021, sentenced to one year in prison and ordered to pay a $1 million fine. The 82-year-old Petit is scheduled to be released from a federal prison in October. His appeal of the conviction remains pending in federal court in New York.
MiMedx has faced other legal challenges, from former employees who alleged they were fired for flagging Petit’s fraud to a challenge last spring from an investor group. Prescience Point Capital Management put up three of its own nominees for the company board. The group withdrew its slate of candidates in May 2021 after MiMedx made changes to its corporate governance.
All major lawsuits and investigations have now been resolved, and Wright said MiMedx has put that era behind it.
“The integrity of the company had been challenged significantly, and many, many people here got hurt,” Wright said. “Our values today are around character and integrity. We’re in this for the long term.”
https://www.ajc.com/news/business/mariettas-mimedx-moving-past-recent-woes/MHQQVYRULRDO3MBAIJNRKOSI3I/
wiredawg
4年前
Had a decent move on 14 Dec 2020: But could be that company that make a big move in 2021...Merry Christmas All
BATON ROUGE, La., Dec. 16, 2020 /PRNewswire/ -- Prescience Point Capital Management, a research-focused, catalyst-driven investment firm, today announced it has issued new research on MiMedx Group Inc. (Nasdaq: MDXG), raising the price target on the leading advanced wound care and therapeutic biologics company to $31 per share. Prescience Point is one of the company's largest shareholders, owning 9 million or approximately 6.5% of the fully-diluted common stock of MiMedx.
Over the past six months, Prescience Point has conducted an in-depth analysis of MiMedx's Amniofix injectable product, which is currently in Phase 2b trials for knee osteoarthritis ("knee OA"), as well as Phase 3 trials for plantar fasciitis and Achillles tendonitis. Following the extensive analysis, which included a comprehensive review of the knee OA and osteoarthritis market, an analysis of clinical data, an analysis of competing treatment options, and conversations with dozens of physicians and patients who have used and been treated with the product, Prescience Point has concluded that Amniofix will be a game-changing treatment for knee OA and other musculoskeletal ailments, which will generate billions of dollars in annual sales for MiMedx.
Prescience Point's research indicates that Amniofix is a far superior treatment for knee OA than the few FDA approved treatments now available for the 20 million people in the U.S. who suffer from this chronic and debilitating condition. Prescience Point's research also indicates that Amniofix is a highly effective treatment for a variety of other musculoskeletal ailments including plantar fasciitis, shoulder osteoarthritis, and ankle osteoarthritis.
Based on the findings of its research, Prescience Point believes that the FDA will approve Amniofix for knee OA and multiple other indications beyond knee OA. Prescience Point also believes that the RMAT designation that the FDA granted to Amniofix could open the door for MiMedx to receive early approval after its Phase 2b knee OA trial, as the FDA can and often does approve fast track treatments following a successful Phase 2 trial.
"Although MiMedx's share price has increased by more than 200% since we published our initial report in January 2019, its shares are still trading at just a fraction of their fair value." said Eiad Asbahi, Founder and Managing Partner of Prescience Point. "We believe that MiMedx's wound care business by itself is worth at least $8 per share. This means that investors who purchase MiMedx shares today are buying the wound care business at a substantial discount and, on top of this, are receiving Amniofix, an asset that we believe is worth multi-billions of dollars, essentially for free."
nole92
5年前
Current MiMedx AmnioFix Trials:
ongoing NCT03485157 A Phase 2B, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized Dehydrated Human Amnion Chorion Membrane Injection as Compared to Saline Placebo Injection in the Treatment of Osteoarthritis of the Knee 2019-12-31
https://clinicaltrials.gov/ct2/show/NCT03485157
ongoing NCT03414255 A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis 2019-12-31
https://clinicaltrials.gov/ct2/show/study/NCT03414255
ongoing NCT03414268 A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis 2020-08-31
https://clinicaltrials.gov/ct2/show/NCT03414268