Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

FDA clears Asensus Surgical 510(k) for articulating instruments

Asensus Surgical (NYSE American:ASXC) received FDA 510(k) clearance for 5 mm diameter articulating instruments, adding to the Senhance Surgical System robotic technology platform. Articulating instruments offer better...

July 28, 2021

Developments

Cybin receives conditional listing approval from NYSE American

Cybin (NEO:CYBN; OTCQB:CLXPF) has received conditional listing approval from the NYSE American stock exchange, under the ticker symbol, CYBN. In a statement, Doug Drysdale, CEO of Cybin, said conditional listing...

July 22, 2021

Developments

Cognetivity ICA test to be deployed in new NHS brain clinic in UK

Cognetivity Neurosciences’ (CSE:CGN; OTCQB:CGNSF) Integrated Cognitive Assessment (ICA) test is to form an integral part of a new and highly innovative clinic in the UK’s National Health Service (NHS) dedicated to...

July 15, 2021

Developments

TransMedics receives positive FDA AdCom vote for OCS Liver System

The FDA’s Gastroenterology and Urology Devices Panel, after a review and discussion, issued a favorable vote in support of approval of TransMedics Group’s (NASDAQ:TMDX) OCS Liver System. The panel voted 14-to-0...

July 15, 2021

Developments

ENA Respiratory begins Phase 1 study of COVID-19 preventative nasal spray

Closely held ENA Respiratory of Australia initiated a Phase 1 human safety study of INNA-051, being developed to activate innate immunity in the nose, the primary entry portal of most respiratory viral infections. A...

July 14, 2021

Developments

Mesosil raises $675,000 seed round led by Archangel and NorthSpring Capital

Mesosil, a closely held company developing the first lifetime-effect antimicrobial materials for dental and medical devices, closed an initial seed round of $675,000 led by the Archangel Network of Funds and NorthSpring...

July 13, 2021

Developments

Hepion posts positive Phase 2a NASH data in AMBITION trial

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that all primary endpoints were met in its Phase 2a AMBITION clinical trial in patients with non-alcoholic steatohepatitis (NASH). The Phase 2a trial was designed to...

July 13, 2021

Developments

FDA approves expanded use for Pivot smoking cessation sensor

Carrot Inc., a closely held digital health company, received expanded use indications for its Pivot Carbon Monoxide Breath Sensor in a new 510(k) clearance by the FDA based on published clinical trial data. As the only...

July 12, 2021

Developments

Lumos Diagnostics raises $63-million (Australian) in IPO

Lumos Diagnostics, with corporate head offices in Melbourne and U.S.-based R&D, commercial operations and manufacturing in both Florida and California, raised $63-million (Australian) in an initial public...

July 8, 2021

Developments

Advaxis and Biosight in merger pact

Advaxis (NASDAQ:ADXS) and closely held Biosight of Israel entered into a definitive merger agreement, with shareholders of Biosight becoming the majority holders of the combined company. Advaxis will be renamed Biosight...

July 7, 2021

Developments

Seelos doses first patient in Part 2 of registration trial with intranasal racemic ketamine

Seelos Therapeutics (NASDAQ:SEEL) dosed the first patient in Part 2 of its registrational proof-of-concept study of SLS-002 (intranasal racemic ketamine) for acute suicidal ideation and behavior in patients with major...

July 6, 2021

Developments

UNITY Biotech posts positive Phase 1 data in advanced vascular eye disease

UNITY Biotechnology (NASDAQ:UBX) announced positive data from its Phase 1 safety study of UBX1325 in patients with advanced disease from diabetic macular edema (DME) or wet age-related macular degeneration (AMD) for...

July 6, 2021

Developments

Titan posts positive results in first studies of TP-2021 implant in chronic pruritus

Titan Pharmaceuticals (NASDAQ:TTNP) reported that an in vivo study of its ProNeura-based human kappa-opioid receptor agonist, TP-2021, implant in an established itch-induced mouse model has demonstrated the...

June 23, 2021

Developments

CymaBay presents positive PBC data at the International Liver Congress

CymaBay Therapeutics (NASDAQ:CBAY) announced positive data at The International Liver Congress from its previously completed Phase 2 study and the ENHANCE Phase 3 study of seladelpar in patients with primary biliary...

June 21, 2021

Developments

Profound’s TULSA-PRO posts better safety, equal efficacy in real-world analysis of prostate cancer partial ablation, BPH

A peer-reviewed paper authored by clinicians and researchers from Germany’s ALTA Klinik and the University Hospital, LMU Munich, and published in Urologic Oncology illustrates that Profound Medical’s...

June 21, 2021

Developments

atai Life Sciences prices $225-million IPO

atai Life Sciences (NASDAQ:ATAI) priced an initial public offering of 15 million common shares at $15 each for gross proceeds of $225-million. In its first day of trading on June 18, the stock jumped $4.45, or 29%, to...

June 18, 2021

Developments

Versant, RA Capital launch LENZ Therapeutics in $47-million series A

A $47-million series A financing from Versant Ventures and RA Capital Management launched LENZ Therapeutics, with a lead late-stage clinical program for presbyopia. Proceeds from the financing will be used to progress...

June 17, 2021

Developments

Clearside Biomedical posts positive safety results in Phase 1/2a wet AMD study

Clearside Biomedical (NASDAQ:CLSD) reported positive safety results from Cohort 1 of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX, an axitinib injectable suspension, which is administered by suprachoroidal...

June 15, 2021

Developments

Lucid Psycheceuticals in pact with UHN to develop neurodegenerative therapeutics

Lucid Psycheceuticals inked a world-wide license agreement with Toronto’s University Health Network (UHN), Canada’s top research hospital, granting Lucid exclusive rights to novel compounds for therapeutic applications...

June 14, 2021

Developments

Hepion Pharmaceuticals to be added to the Russell Microcap Index

Hepion Pharmaceuticals (NASDAQ:HEPA) is set to join the Russell Microcap Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28. Membership in the...

June 9, 2021

Developments

Veterinary healthcare company evaluating IntelGenx VetaFilm platform

IntelGenx (TSXV:IGX; OTCQB:IGXT) entered into a materials transfer agreement with an undisclosed global veterinary healthcare company to evaluate IntelGenx’s proprietary VetaFilm platform in cats. Based on a...

June 8, 2021

Developments

Lancet article discusses benefits of PharmaJet Tropis ID needle-free delivery

A systematic review and meta-analysis published in the April 30, 2021 issue of The Lancet strengthens evidence that fractional dose delivery is a viable alternative to full dose inactivated polio vaccine (IPV) and...

June 3, 2021

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