DiagnosTear, the dry eye diagnostic subsidiary of BioLight Life Sciences (TASE:BOLT), hopes to file by the end of 2017 for CE Mark approval in Europe and begin a pivotal trial in the U.S. in mid-2018 with its TeaRx device to aid in the diagnosis and monitoring of dry eye syndrome (DES).Read More
Since its founding 15 years ago, Mazor Robotics (NASDAQ, TASE:MZOR) has overcome challenges typical to medical device startups to become the leader and possibly the standard of care in spine robotics surgery.Read More
BiondVax Pharmaceuticals (NASDAQ, TASE:BVXV) expects to be Phase 3 ready in 2018 to begin pivotal testing in Europe of a universal flu vaccine with the potential to provide multi-season and multi-strain protection against all human influenza virus strains, both seasonal and pandemic.Read More
BioTime (NYSE MKT, TASE:BTX) has multiple data milestones scheduled this year in its two lead regenerative medicine programs: OpRegen in dry AMD and Renevia in facial aesthetics.Read More
With approvals in Europe and Israel for its CellDetect non-invasive test for recurrence of bladder cancer, Micromedic Technologies (TASE:MCTC) is seeking FDA approval for a pivotal trial expected to begin in the first quarter next year with bladder cancer patients.Read More
As president and CEO of BioView (TASE:BIOV), Dr. Alan Schwebel has led the company, a world leader in automated fluorescence in situ hybridization (FISH) cell imaging and analysis, since 2009. Dr. Schwebel, who has more than 30 years of experience in senior management positions in leading medical device and medical diagnostic companies, joined BioView in 2002 as VP of sales and marketing. In this interview with BioTuesdays.com, he discusses the company’s cutting-edge technology, exclusive worldwide distribution and development agreements with Abbott Molecular and a new lung cancer diagnostic test.Read More
BioLight Life Sciences Investments (OTCQX:BLGTY; TASE:BOLT) is now defining itself as an ophthalmology company after spending several years assembling a cluster of investments in the sector as well as in cancer diagnostics.
“We believe there is a huge value potential from the ophthalmic therapeutics and diagnostics we have gathered,” CEO, Suzana Nahum Zilberberg, says in an interview with BioTuesdays.com.
“These technologies target diseases with unmet medical needs that require innovation to treat large and growing patient populations, especially in the elderly,” she adds.
While BioLight intends to retain its controlling ownership position in its Micromedic cancer diagnostics portfolio, “on a daily basis, we are focusing on ophthalmology,” she contends.Read More
Kadimastem (TASE:KDST) hopes its pre-IND meeting with the FDA in November will outline a protocol for a Phase 1/2a clinical trial of its stem cell therapy for the treatment for Amyotrophic Lateral Sclerosis (ALS) to begin at the end of 2016.
“Our plan is to begin the trial in Israel under an IND and then continue it in the U.S.,” Arik Hasson, EVP for R&D, says in an interview with BioTuesdays.com.
Dr. Hasson explains that Kadimastem’s technology platform enables the differentiation of stem cells into a range of functional human cells for regenerative medicine, including neuron-supporting cells of the brain for diseases of the central nervous system, such as ALS, as well as pancreatic cells that produce and secrete insulin for Type 1 diabetic patients.Read More
Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) is preparing the protocol for its next advanced psoriasis trial with its CF101 oral drug candidate, even though an earlier Phase 2/3 study did not meet its primary endpoint.
The earlier trial was designed to show a statistically significant improvement in the Psoriasis Area Severity Index (PASI) 75 score, relative to placebo, after 12 weeks of treatment. PASI 75 refers to 75% clearing of a patient’s lesions.
However, further analysis of the entire study period revealed that by 32 weeks of treatment with CF101, 35% of patients with moderate-to-severe plaque psoriasis achieved PASI 75 scores, while the mean percent improvement in PASI score was 57%.Read More
As a co-founder and CEO of Cellect Biotechnology (TASE:CLBD), Dr. Shai Yarkoni has more than 15 years of clinical and management experience in the biopharmaceutical industry. He is the founder of five start-ups in the life-sciences field, and serves on the board of noted institutes in Israel and the world. Prior to founding Cellect, he was CEO of Target-In, and CTO and VP R&D of Collgard Biopharmaceutical, a tissue therapeutics company. Dr. Yarkoni is a board certified Ob/Gyn and is the author of over 60 scientific papers. In this interview with BioTuesdays.com, he discusses Cellect’s unique approach to facilitating immune stem cell selection for bone marrow transplantation.Read More
After five years of selling its skin rejuvenation devices to medical professionals through a distributor, EndyMed Medical (TASE:ENDY) has launched a U.S.-based direct sales operation through subsidiary, EndyMed USA.
“During the second half of 2014, we expanded the sales force team to cover all major markets in the U.S. and significantly increased our U.S.-based marketing activity,” Elad Magal, CEO, says in an interview with BioTuesdays.com.
“Based on increased demand for our proprietary 3DEEP technology, we now have access to doctors everywhere in the U.S. and at all major national dermatological and aesthetic conferences,” he adds.Read More
As a co-founder of BiondVax Pharmaceuticals (TASE:BNDX), Ron Babecoff has led the Israeli developer of a universal flu vaccine since its inception in 2003.Read More
Using an unique and innovative technology known as peripheral arterial tone (PAT), Itamar Medical (TASE:ITMR) is detecting the functioning and health of arteries through a finger sensor for the diagnosis of sleep apnea and heart disease.Read More
XTL Biopharmaceuticals (NASDAQ:XTLB; TASE:XTL) is aiming to begin a Phase 2b clinical trial in the first half of 2015 with its hCDR1 peptide to treat patients with systemic lupus erythematosus (SLE).Read More
With a PDUFA target date of Feb. 3, 2014 for its migraine drug, RHB-103, and NDA filing planned for the first quarter of 2014 for the anti-emetic drug, RHB-102, RedHill Biopharma (NASDAQ,:RDHL; TASE:RDHL) is now focusing its efforts on its flagship programs: RHB-104 for Crohn’s disease and RHB-105 for Helicobacter pylori (H. pylori).Read More
Results of a recent clinical trial of Vaxil Bio’s (TASE:VAXL) ImMucin cancer vaccine in patients with multiple myeloma has validated the company’s VaxHit technology by demonstrating safety and a strong immune response in all patients.Read More