Frequency Therapeutics (Woburn, Mass.) recently announced data related to its experimental FX-322 drug. The small Phase 1/2 study, which was published in Otology & Neurotology, found hearing improvements in adults with age-related sensorineural hearing loss. At present, there are no FDA-approved drugs for preventing or restoring such hearing loss, although administering steroids can facilitate recovery […]
Regenerative Medicine
Graphite Bio closes $150M Series B
Graphite Bio announced that it closed an oversubscribed Series B financing round with proceeds totaling $150 million. South San Francisco-based Graphite Bio’s funding is earmarked for the expansion and advancement into the clinic of its pipeline of investigational targeted gene integration therapies with curative potential for serious diseases, according to a news release. The company […]
Locate Bio lands FDA breakthrough nod for bone infection device
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 […]
BioCardia wins CE Mark renewal for Helix, Morph catheters
BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]
PolarityTE launches two chronic wound treatment trials
PolarityTE (NSDQ:PTE) said it has begun enrolling patients in two new randomized clinical trials of its SkinTE regenerative tissue product for chronic wounds. The trials will evaluate the SkinTE’s effectiveness in treating diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). SkinTE is a human cellular and tissue-based product designed to regenerate full-thickness, functional skin […]
PolarityTE reveals SEC investigation
PolarityTE (NSDQ:PTE) this week revealed that it is the target of an SEC investigation into possible violations of federal securities laws. The Salt Lake City, Utah-based company said that it received a copy of a formal order of investigation from the SEC on March 4, exploring possible violations of fraud and price manipulations, according to an […]
Frequency Therapeutics raises $42m for hearing regeneration drug
Frequency Therapeutics said today that it closed a $42 million Series B round to support the clinical development of its hearing regeneration drug, FX-322. The company is slated to publish top-line data from an ongoing Phase I/II study of FX-322 in the first half of the year. The Series B round was led by Taiwania […]
PolarityTE registers bone repair product with FDA
PolarityTE (NSDQ:PTE) said last week that it registered its bone repair product, OsteoTE, with the FDA. The Utah-based company’s technology is an autologous, homologous product designed to repair, reconstruct and replace bone using a patient’s own cells. In preclinical trials, OsteoTE regenerated bone with similar characteristics to natural bone, according to PolarityTE. The company also […]
PolarityTE aims to ‘wage war on skin grafts’ with regenerative tech
PolarityTE wants to eliminate skin grafts with its platform of regenerative technology. The Utah-based biotech is still new to the industry, but co-founders Denver Lough and Ned Swanson are betting that their company can take on the clinical standard of care for wound management. “No other product, whether it be a drug, a biologic device, […]
Following first profitable quarter, Vericel’s CEO looks to grow portfolio of autologous cell therapy products
In its latest financial results, Cambridge, Mass.-based Vericel (NSDQ:VCEL) saw sales climb 60% for its permanent skin-replacement product, Epicel, designed for patients with severe burns. Sales for its autologous cellular scaffold, Maci, were up 20% following its launch to the commercial market. Vericel’s growing product adoption helped to fuel the company’s first profitable quarter, according to […]
