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mimedx

MiMedx confirms shelf registration to sell $350M

September 8, 2021 By Sean Whooley

MiMedx

MiMedx (NSDQ:MDXG) announced today that its recently filed shelf registration with the SEC has become effective. Marietta, Georgia-based MiMedx last month filed the shelf registration statement on Form S-3 with the SEC with the intent to be allowed to sell up to $350 million in various types of securities over the next three years once […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Regenerative Medicine Tagged With: mimedx

MiMedx files SEC shelf registration to sell up to $350M in securities

August 27, 2021 By Sean Whooley

MiMedx

MiMedx (NSDQ:MDXG) announced today that it filed a shelf registration statement on Form S-3 with the SEC. Marietta, Ga.-based MiMedx, which develops AmnioFix, a micronized dehydrated human amnion/chorion membrane (dHACM) injection as regenerative medicine, will be allowed to sell up to $350 million in various types of securities over the next three years once the […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Regenerative Medicine Tagged With: mimedx, Securities and Exchange Commission (SEC)

MiMedx top brass resign amid internal accounting investigation

July 2, 2018 By Chris Newmarker

MiMedx

MiMedx CEO Parker H. “Pete” Petit and COO and President William C. “Bill” Taylor have resigned as a board-directed independent investigation continues into accounting practices, Marietta, Ga.–based MiMedx (Nasdaq: MDXG) announced today. Petit and Taylor’s exit comes after recent departures of MiMedx’s CFO and corporate controller and treasurer. In addition to the resignations of top brass, the […]

Filed Under: Business/Financial News, Featured, Grafts, Legal News Tagged With: mimedx

MiMedx wins FDA regenerative med status for AmnioFix

March 12, 2018 By Sarah Faulkner

MiMedx

MiMedx (NSDQ:MDXG) won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week. The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee. “The FDA’s RMAT designation for AmnioFix Injectable is […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Orthopedics, Pharmaceuticals, Regenerative Medicine, Regulatory/Compliance, Wall Street Beat Tagged With: mimedx

MiMedx shares tumble on internal accounting investigation, delayed 2017 earnings

February 20, 2018 By Fink Densford

MiMedx

MiMedx (NSDQ:MDXG) shares have lost nearly a third of their value today after the company announced it is delaying the release of its 2017 financial results due to an internal investigation into alleged issues with sales and distribution practices at the company. The Marietta, Ga.-based company said that its board’s audit committee has tapped a group of […]

Filed Under: Business/Financial News, Featured, Wall Street Beat Tagged With: mimedx

MiMedx closes Stability Biologics sale

October 6, 2017 By Sarah Faulkner

MiMedx

MiMedx (NSDQ:MDXG) said this week that it completed the divestiture of its subsidiary, Stability Biologics, back to the former stockholders of Stability, Inc. The deal, which closed on Sept. 30, included a promissory note issued by Stability Biologics for $3.5 million in favor of MiMedx. “When we signed the definitive agreement for the divestiture, we communicated […]

Filed Under: Featured, Regenerative Medicine, Surgical, Wall Street Beat Tagged With: mimedx

MiMedx files IND for Ph2 AmnioFix osteoarthritis trial

September 19, 2017 By Sarah Faulkner

MiMedx

MiMedx (NSDQ:MDXG) said today that it filed an IND with the FDA for a Phase II trial of its AmnioFix product in patients with osteoarthritis of the knee. The 318-patient study is designed to compare the safety and efficacy of MiMedx’s micronized dehydrated human amnion/chorion membrane (dHACM) injection with a 0.9% sodium chloride USP placebo injection. […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Orthopedics, Wall Street Beat Tagged With: mimedx

MiMedx wins FDA nod for AmnioFix pivotal trial

September 7, 2017 By Sarah Faulkner

MiMedx

MiMedx (NSDQ:MDXG) said today that the FDA has approved its Phase III Achilles tendonitis trial. The 158-patient study is designed to compare the company’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. The trial, which is the company’s second late-stage study of AmnioFix, will start […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Orthopedics, Wall Street Beat Tagged With: mimedx

MiMedx files IND for Achilles tendonitis trial

August 7, 2017 By Sarah Faulkner

MiMedx

MiMedx (NSDQ:MDXG) said today that it filed an IND application with the FDA for the company’s late-stage Achilles tendonitis trial. The 158-patient study is designed to compare MiMedx’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. If approved, the trial will be the second […]

Filed Under: Clinical Trials, Featured, Orthopedics, Pain Management, Regenerative Medicine, Wall Street Beat Tagged With: mimedx

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