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Regenerative Medicine

FDA grants breakthrough device designation for Theradaptive’s spinal fusion implant

November 19, 2021 By Sean Whooley

Theradaptive announced today that it received FDA breakthrough device designation for its Osteo-Adapt SP spinal fusion implant. Frederick, Maryland–based Theradaptive designed the Osteo Adapt SP implant for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis or retrolisthesis. According to a news release, the company touts its regenerative implants as best-in-class with designs […]

Filed Under: Food & Drug Administration (FDA), Implants, Orthopedics, Regenerative Medicine, Regulatory/Compliance, Spine Tagged With: FDA, Theradaptive

Integra Lifesciences announces new CEO

October 28, 2021 By Chris Newmarker

Integra LifeSciences (NSDQ:IART) announced today that former Barco CEO Jan D. De Witte will take over the corner office at Integra by the end of the year. De Witte left Barco effective September 1. He will succeed Peter J. Arduini, who is leaving Integra Lifesciences to lead GE Healthcare. The top spot at Integra will […]

Filed Under: Business/Financial News, Featured, Neurological, Regenerative Medicine, Surgical, Wound Care Tagged With: Barco, Integra LifeSciences, Personnel Moves

BICO’s Cytena launches C.Station automated cell line development platform for antibody and gene therapies

October 19, 2021 By Jim Hammerand

  BICO Group subsidiary Cytena today announced the launch of its C.Station platform for automating the development of stable cell lines. Cytena said in a news release that C.Station is a user-friendly platform that covers the entire cell line development workflow, from single-cell cloning of transfected cells to the selection of high-producing clones and upscaling. Get the […]

Filed Under: Biotech, Blog, Lab Instruments & Supplies, News Well, Regenerative Medicine, Software / IT

MiMedx confirms shelf registration to sell $350M

September 8, 2021 By Sean Whooley

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 the shelf registration […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Regenerative Medicine Tagged With: MiMedx Group Inc.

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

August 27, 2021 By Sean Whooley

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 SEC […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Regenerative Medicine Tagged With: MiMedx Group Inc., Securities & Exchange Commission (SEC)

Tenaya Therapeutics prices $180M IPO for targeted therapies

July 30, 2021 By Sean Whooley

Tenaya Therapeutics announced that it priced an underwritten, upsized initial public offering of common stock worth $180 million. South San Francisco–based Tenaya develops therapies for rare generic disorders and more prevalent heart conditions through gene therapy, cellular regeneration and precision medicine. The company is actively exploring different routes of administration and different infusion- and injection-based methods […]

Filed Under: Business/Financial News, Cardiovascular, Drug Pumps, Drug-Device Combinations, Featured, Funding Roundup, Initial Public Offering (IPO), Regenerative Medicine, Wall Street Beat Tagged With: Tenaya Therapeutics

FDA approves Stratatech’s StrataGraft skin graft

June 15, 2021 By Danielle Kirsh

Mallinckrodt‘s (NYSE: MNK) Stratatech today received FDA approval for its StrataGraft for treating adult patients with thermal burns. The Bedminister, N.J.-based company designed StrataGraft to treat thermal burns that have intact dermal elements, or remaining deep skin layers, for which surgical intervention is clinically indicated. “Serious burns can be an incredibly difficult injury to treat and can […]

Filed Under: Food & Drug Administration (FDA), Regenerative Medicine, Regulatory/Compliance Tagged With: Mallinckrodt, Stratatech Corp.

MIT, Indian researchers grow tiny brains in 3D-printed bioreactor

April 6, 2021 By Sean Whooley

Scientists in Cambridge, Mass. and Chennai, India, are touting self-organizing brain tissue growth in a 3D-printed system. Published results in Biomicrofluidics highlight the work of the Massachusetts Institute of Technology (MIT) and Indian Institute of Technology Madras scientists, who have grown small amounts of the self-organizing brain tissue, known as organoids, in a tiny 3D-printed system that […]

Filed Under: Biotech, Featured, Neurological, Regenerative Medicine, Research & Development Tagged With: 3D printing, Indian Institute of Technology Madras, mit

Magenta Therapeutics rises on Street-beating Q4

March 3, 2021 By Sean Whooley

Magenta Therapeutics (NSDQ:MGTA) shares ticked up today on fourth-quarter earnings that topped the consensus forecast. The Cambridge, Mass.-based stem cell transplantation technology developer posted losses of -$18.2 million, or -38¢ per share for the three months ended Dec. 31, 2020, marking a 21.8% bottom-line gain. Get the full story at our sister site, Drug Delivery Business […]

Filed Under: Business/Financial News, Drug-Device Combinations, MassDevice Earnings Roundup, Regenerative Medicine, Stem Cells, Wall Street Beat Tagged With: magentatherapeutics

Could this hydrogel repair a broken heart?

March 2, 2021 By Nancy Crotti

European researchers have developed an injectable hydrogel that could help repair and prevent further heart muscle damage after a heart attack. The therapeutic effect of multiple injections of this hydrogel into the cardiac tissue was assessed during the first preclinical study of its kind, demonstrating its efficacy for cardiac tissue remodeling following a heart attack, […]

Filed Under: Cardiovascular, Featured, Regenerative Medicine, Research & Development Tagged With: hydrogel, National University of Ireland Galway, University of Gothenburg, University of Milano-Bicocca, University of Valladolid, University Paris Est

Locate Bio lands FDA breakthrough nod for bone infection device

January 7, 2021 By Nancy Crotti

Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]

Filed Under: Featured, Food & Drug Administration (FDA), Implants, Orthopedics, Regenerative Medicine, Regulatory/Compliance Tagged With: FDA, Locate Bio

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