Rgenix raises $40M to develop novel cancer drugs

Biopharma startup Rgenix said it has raised $40 million in Series C financing to further develop its clinical and pre-clinical oncology programs and for general corporate purposes.

New York City-based Rgenix has discovered several novel RNA-regulated cancer targets that drive tumor growth and cancer progression, according to its website. These targets regulate key components of the tumor microenvironment, including immune cells and cancer metabolism pathways.

Get the full story on our sister site, Drug Delivery Business.

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Glympse Bio raises $22M for disease-detecting sensors

Sensor-driven disease detection company Glympse Bio has raised $22 million in a Series A round to fund clinical trials for its technology.

The Cambridge, Mass.-based company uses bioengineered activity sensors transported to the site of disease in patients to investigate biological targets such as proteases – a class of enzymes that drive critical disease pathways. Once a disease is located, the sensor emits a signal that can be detected noninvasively from the recipient’s urine, according to the company.

A spinout from Massachusetts Institute of Technology, Glympse Bio is applying machine learning algorithms to develop a proprietary, whole-genome database of enzymes and sensors capable of targeting all clinically-relevant proteases. Its technology platform can be extended to multifunctional enzymes including kinases, glycases, and lipases that may indicate the presence of fibrosis, cancer, immunological and infectious diseases.

Glympse Bio’s can be administered in a minimally invasive manner and the analytical read-out can be selected based on the disease characteristics or market needs for the test, according to the company’s website. Its lead indication targets non-alcoholic steatohepatitis (NASH), which causes fibrosis and scarring of the liver and is believed to afflict more than 100 million people worldwide, including over 15 million in the United States alone. The company said it has signed multiple collaborations in NASH with pharmaceutical companies.

The financing round was co-led by venture capital firms LS Polaris Innovation Fund and ARCH Ventures. New investors Charles River Ventures, Gilead Sciences, Yonghua Capital, and Inevitable Ventures contributed to the round,  joined by existing investors GreatPoint Ventures, Heritage Provider Network and Rivas Capital. This financing follows an initial $6.6 million seed round in 2015 led by Kiran Mazumdar-Shaw at Biocon India Ltd. and Theresia Gouw at Aspect Ventures.

Polaris’ Amy Schulman, diagnostics industry veteran Stan Lapidus, and seven-time Forbes’ Midas List recipient Theresia Gouw will join Glympse’s board of directors, the company added.

“Glympse has brought together world-class science and people to achieve a fundamental breakthrough for in vivo sensing and monitoring of diseases involved in fibrosis, immune response, infectious diseases, and a broad range of cancers,” Schulman said in a prepared statement. “We were impressed by the company’s commitment to a therapeutic model which will be well aligned with the interests of payors, physicians, and most of all, patients.”

 

 

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Medtech reporting would change under new opioid law

A section of the recently-passed bill to address the opioid crisis could have implications for medtech.

The 250-page Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act) contains a provision that would require manufacturers of certain medical devices, drugs and biologics covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments or other transfers of value made to “covered recipients.”

“Covered recipients,” as originally written in the sunshine provision of the Affordable Care Act, were only physicians and teaching hospitals. Section 6111 of SUPPORT would expand that to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwives as of January 1, 2022. Also known as H.R. 6, the bill has passed both houses of Congress and is awaiting President Trump’s signature.

The reporting changes needn’t have anything to do with opioids, and this provision’s effective date is ambiguous, according to an FDA law blog post by the Washington, D.C. law firm Hyman, Phelps & McNamara. Stay tuned for CMS to clear this up in forthcoming regulations.

 

 

 

 

 

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Certain polyethylene-lined hips may last longer than others

The DePuy Marathon total hip, made with a highly cross-linked polyethylene liner

Researchers in New Zealand found that artificial hip liners made of highly-cross-linked polyethylene showed less wear 10 years after implantation than liners made of conventional ultra-high-molecular-weight polyethylene.

Patients whose hip liners were made of highly cross-linked polyethylene also had a significantly lower prevalence of osteolysis and revision surgery, according to a report in Orthopedics Today.

That’s because cross-linking ties molecules together in a lattice-like matrix, Larry Wallace, senior staff scientist at Spectrum Plastics Group, told Medical Design & Outsourcing. The structure of regular high-density polyethylene is crystalline, Wallace told us.

Get the full story on our sister site, Medical Design & Outsourcing.

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Egypt CAPA expands medical device oversight regulations

By Stewart Eisenhart, Emergo Group

Expanded medical device registration requirements in Egypt remain set to come into effect September 1, 2018, but affected companies should be familiarizing themselves now with new Central Administration of Pharmaceutical Affairs (CAPA) processes.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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BlueWind posts positive follow-up study results

BlueWind Medical’s implantable tibial stimulation device

Neurostim developer BlueWind Medical reported positive results from a follow-up study of patients using its implantable tibial nerve stimulator for overactive bladder (OAB).

Renova iStim is a leadless, miniature, wireless neurostimulation platform designed for the treatment of multiple clinical indications. Three years after implantation of the BlueWind’s Renova iStim device, 75% of patients experienced at least a 50% long-term reduction in symptoms. Patients experienced a durable, long-term, effect of urinary urge incontinence relief in “leaks” (50% of patients) and in “large leaks” (80% of patients). No severe adverse events were reported throughout the follow-up study, according to the Herzliya, Israel-based company.

Get the full story on our sister site, Medical Design & Outsourcing.

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Philips buys military health-monitoring software

Chief Master Sgt. Robert Bean, an Air Force pararescue jumper, demonstrates how Batdok can be worn on the wrist, displaying the health status of multiple patients. (Photo by
Richard Eldridge/US Air Force)

Philips Healthcare has signed a non-exclusive patent license agreement with the U.S. Air Force Research Laboratory for a mobile software application that provides integrated, real-time patient monitoring.

Known as Batdok, an acronym for Battlefield Assisted Trauma Distributed Observation Kit, the software application was developed by the 711th Human Performance Wing at Wright-Patterson Air Force Base. Designed as a wearable technology, it allows a medic to efficiently monitor multiple casualties in the field using a smartphone or tablet. Adaptation for civilian applications will advance telemedicine capabilities, the company said.

Get the full story on our sister site, Medical Design & Outsourcing.

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$3.8 million federal grant targets suicide research

This image is from Marcel Just and David Brent’s initial study and shows the brain activation pattern for ‘death’ in participants who had made a suicide attempt (left). The image on the right depicts the activation pattern for ‘death’ in control participants. (Image courtesy of Carnegie Mellon University)

Researchers using brain imaging to identify people with suicidal thoughts just landed a $3.8 million grant from the National Institute for Mental Health.

Marcel Just of Carnegie Mellon University and David Brent of the University of Pittsburgh will use the money to advance their research analyzing the alterations in how brains represent certain concepts, such as death, cruelty and trouble. Their initial study was published in Nature Human Behaviour in 2017.

Get the full story on our sister site, Medical Design & Outsourcing.

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Is your medical device affected by new EU regulations?

By Ronald Boumans and Stewart Eisenhart, Emergo Group

Now that the European Medical Device Regulation (MDR) is widely available in draft form, manufacturers and other industry participants can more accurately predict key issues that will affect them—including how and whether the scope of the new regulations covers their devices.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Avinger asks for FDA approval of small-vessel PAD device

Avinger (NASDAQ:AVGR) has filed for 510(k) clearance of its Pantheris small-vessel “lumivascular” atherectomy device for treatment of peripheral artery disease (PAD).

The Pantheris small vessel (SV) device extends the company’s line of  Pantheris catheters, the first and only image-guided atherectomy devices for the treatment of PAD, which is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller-diameter vessels and more distal regions of the vasculature.

Get the full story on our sister site, Medical Design & Outsourcing.

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