Glucotrack (Nasdaq:GCK) announced today that it completed the first preclinical study of its implantable continuous blood glucose monitor (CBGM). Rutherford, New Jersey-based Glucotrack aimed to assess the implant technique and device safety in the study. Additionally, the study used a small sample size of sensors to determine device functionality. Despite no intent to conduct an […]
Implants
Elutia submits drug-eluting biomatrix for use with cardiac implants to FDA
Elutia (Nasdaq:ELUT) announced today that it submitted a 510(k) premarket notification to the FDA for its drug-eluting biomatrix. The company designed its next-generation CanGarooRM for use with cardiac implantable electronic devices like pacemakers and defibrillators. A bioenvelope, CanGarooRM stabilizes the implantable devices. Made from a natural biomaterial that promotes a regenerative healing response, the biomatrix […]
FDA approves Glaukos iDose TR glaucoma-treating drug delivery implant
Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant. The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle […]
Encellin closes $9.9M financing to support implantable drug delivery pouch
Encellin announced today that it closed a $9.9 million financing round to support its cell encapsulation platform. The San Francisco-based company develops an encapsulated cell replacement therapy (EnCRT). It isolates therapeutic cells from the body’s immune system to help therapeutic cells survive in the body. Once implanted, cells within the EnCRT can exchange biomolecules with […]
GlucoTrack transitions strategic focus to long-term implantable CGM
Glucotrack (Nasdaq:GCTK) President and CEO Paul V. Goode today issued a statement to shareholders outlining strategic changes. Goode’s letter to shareholders announced a redefined strategic direction. The company wants to move closer to becoming a leader in the diabetes market. According to Goode, the diabetes market has undergone a transformation over recent years. He attributed […]
Senseonics posts mixed Q3, iCGM designation expected next year
Senseonics (NYSE:SENS) shares remained mostly unchanged today on third-quarter results that came in mixed compared to the consensus forecast. Shares of SENS dipped 0.3% at 51¢ apiece before the market opened today. The Germantown, Maryland-based implantable continuous glucose monitor (CGM) maker posted losses of $24.1 million. That equals 4¢ per share on sales of $6.1 […]
iStar Medical continues European MINIject rollout with first procedures in Ireland
iStar Medical announced today that it expanded the commercial rollout of its MINIject device with the first implants in Ireland. MINIject, a minimally invasive glaucoma surgery (MIGS) device, treats open-angle glaucoma. Currently the only commercially available supraciliary MIGS implant, it has demonstrated meaningful and sustained performance, plus a favorable safety profile. The device combines the […]
Senseonics completes 365-day CGM study cohort
Senseonics (NYSE:SENS) announced today that it completed its ENHANCE pivotal clinical study adult cohort for its 365-day Eversense CGM. Germantown, Maryland-based Senseonics’ ENHANCE study recorded the completed 365-day visit for the final study patient. The study evaluates the year-long implantable continuous glucose monitor in adults. It also has a pediatric cohort (ages 14 to 18), […]
Elutia raises $26M for drug-eluting biomatrix tech
Elutia (Nasdaq:ELUT) announced today that it entered into a securities purchase agreement worth total proceeds of $26.2 million. The drug-eluting biomatrix company expects the private placement financing to result in initial gross proceeds of approximately $10.5 million. The full exercise of warrants would add $15.8 million to reach a total of $26.2 million. Silver Spring, […]
Senseonics enters into $50M loan facility
Senseonics (NYSE:SENS) announced today that it entered into a $50 million loan facility with Hercules Capital. The Germantown, Maryland-based long-term, implantable continuous glucose monitor (CGM) maker drew $25 million upon closing. Senseonics CFO Rick Sullivan said the facility provides increased financial flexibility for the company. It looks to continue collaborating with Ascensia Diabetes Car to […]
