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Fink Densford

Antidote looks to leverage AI, travel e-commerce tech to improve clinical trial enrollment

January 31, 2018 By Fink Densford

Antidote

Clinical trial artificial intelligence company Antidote is looking to improve access to and enrollment in clinical trials using technology from the e-commerce world, according to a Wired report. Former travel and airline fare aggregator Kayak VP Pablo Graiver is heading the operation, which streamlines access to clinical trials for patients seeking them out. Read the […]

Filed Under: Business/Financial News, Clinical Trials, Featured Tagged With: antidote

BioCardia files 2nd FDA IDE bid for CardiAMP chronic myocardial ischemia, refractory angina study

January 5, 2018 By Fink Densford

BioCardia

BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy for treating chronic myocardial ischemia and refractory angina as it seeks a second indication. The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate […]

Filed Under: Cardiovascular, Clinical Trials, Featured, Food & Drug Administration (FDA), Regenerative Medicine Tagged With: BioCardia

Integrity Applications inks exclusive Dutch distro deal for GlucoTrack

December 28, 2017 By Fink Densford

Integrity Applications

Integrity Applications said today it inked an exclusive distribution deal with MediReva B.V. to distribute its GlucoTrack non-invasive glucose measuring device in the Netherlands, effective December 22. Integrity Application’s flagship GlucoTrack is a sensor that clips to the earlobe and uses a combination of metrics to determine blood glucose based on physiological changes in the body. […]

Filed Under: Business/Financial News, Diabetes, Featured Tagged With: integrityapplications

Spectral Medical wins FDA nod for Spectral Apheresis Machine

December 28, 2017 By Fink Densford

Spectral Medical

Spectral Medical (TSX:EDT) said this month it won FDA 510(k) clearance for its Spectral Apheresis Machine designed for use in continuous renal replacement therapy and therapeutic plasma exchange. The SAM device was developed to support commercialization of the company’s Toraymyxin, or PMX therapy, to enable intensive care units to be able to safely and efficiently deliver […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: spectralmedical

Beta Bionics raises $2m

December 28, 2017 By Fink Densford

Beta Bionics

Beta Bionics has raised $2.4 million in a new round of equity and securities financing, according to an SEC filing posted this week. A total of 11 anonymous investors have participated in the round, though the company has not yet stated who has joined or how it plans to spend funds raised. The company is […]

Filed Under: Business/Financial News, Diabetes, Featured Tagged With: Beta Bionics

Medherant raises $5m to move transdermal ibuprofen patch to clinical trials

December 12, 2017 By Fink Densford

Medherant

Transdermal drug-delivery company Medherant said yesterday it raised $5.1 million (GBP £3.8 million) in a funding round as it looks to move its drug-delivering ibuprofen Tepi Patch into clinical development early next year. The funding round was led by majority shareholder Mercia Technologies and joined by existing shareholders and new private investors, the Coventry, U.K.-based […]

Filed Under: Business/Financial News, Clinical Trials, Drug-Device Combinations, Pain Management, Pharmaceuticals Tagged With: medherant

Intersect ENT wins FDA nod for Sinuva polyp-disease-treating sinus implant

December 11, 2017 By Fink Densford

Intersect ENT

Intersect ENT (NSDQ:XENT) said today it won FDA approval for its Sinuva mometasone furoate sinus implant designed to treat recurrent nasal polyp disease in patients who have previously had ethmoid sinus surgery. The Sinuva device is designed to be implanted during a routine physician office visit and expands into the sinus cavity to deliver an anti-inflammatory steroid […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Otolaryngology Ear, Nose & Throat, Regulatory/Compliance Tagged With: Intersect ENT Inc.

Regeneron scraps Eylea combo therapy after disappointing early trial results

November 29, 2017 By Fink Densford

Regeneron

Regeneron (NSDQ:REGN) is scrapping plans for a new combination drug pairing its Eylea with angiopoietin2 antibody nesvacumab after disappointing results from mid-stage clinical trials, according to a press release it published on Monday. Regeneron received results from 2 Phase 2 trials, the Ruby and Onyx studies, which reported that the combination drug “did not provide sufficient differentiation […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Regeneron

Rebiotix expands Phase I trial of microbiota product after initial study success

November 29, 2017 By Fink Densford

Rebiotix

Rebiotix said today it is expanding the Phase 1 study of its investigative RBX7455 drug designed to prevent recurrent Clostridium difficile infections after initial success in its two introductory cohorts in the trial. The Roseville, Minn.-based company’s RBX7455 is a lyophilized, non-frozen oral capsule formation of its Microbiota Resoration Therapy which it says is designed to “rehabilitate […]

Filed Under: Clinical Trials, Featured, Pharmaceuticals Tagged With: rebiotix

Wearable CGM biosensor dev BioLinq raises $10m

November 27, 2017 By Fink Densford

Biolinq

Biosensor developer Biolinq said today it closed a $10 million Series A financing round to support its wirelessly-enabled biosensor patch designed for continuous monitoring of biomarkers, with an initial focus on monitoring glucose in diabetes patients. The round was led by M Ventures in collaboration with Hikma Ventures and joined by Grey Sky Venture Partners, […]

Filed Under: Business/Financial News, Diabetes, Featured, Patient Monitoring Tagged With: biolinq

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