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December 3, 2019 Bioscience Notebook

UPenn to pilot Guilford firm’s portable MRI; Shelton anti-viral developer gets $2M lifeline 

PHOTO | Contributed Hyperfine Research Inc.'s portable, point-of-care MRI.
By Natalie Missakian

The University of Pennsylvania has begun testing whether a portable MRI prototype developed by a Guilford company can help doctors diagnose and monitor hydrocephalus, a brain disease caused by abnormal buildup of fluid.

Hyperfine Research Inc. announced its partnership with Penn Medicine on Monday. 

The five-year-old startup, founded by genetics pioneer and New Haven native Jonathan Rothberg and housed in his 4Catalyzer incubator in Guilford, unveiled the portable, point-of-care MRI at a conference of emergency physicians in Denver in October. 

While traditional MRI machines are large and confined to protected rooms, Hyperfine’s MRI rolls up to a patient’s bedside, plugs into a standard wall outlet and is operated via an iPad. 

Yale New Haven Hospital was the first to pilot the device in its neuro intensive care unit.

Penn Medicine’s team will evaluate the feasibility of imaging hydrocephalus patients and will evaluate its diagnostic capabilities compared to conventional MRI and CT scanners, Hyperfine said.

Hydrocephalus is caused by a buildup of cerebrospinal fluid, causing fluid-filled spaces of the brain to become enlarged. It can lead to headaches, dizziness, cognitive impairment, gait disturbances and death in severe cases.

Doctors treat the condition by inserting a tube to drain the fluid, which sometimes must be adjusted or replaced, requiring routine monitoring.

“We want to see if this kind of device can provide a simple, safe and cost-effective way to follow such patients in a physician’s office,” said Joel Stein, MD, assistant professor of radiology at UPenn’s Perelman School of Medicine, in a statement.

The device is still awaiting clearance by the U.S. Food & Drug Administration. The company expects to launch it commercially next year.

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NanoViricides Inc., a Shelton antiviral developer that has been running low on cash as it tries to propel its first drug candidate into human trials, has received a $2 million boost from its founder and president. 

The company said Anil R. Diwan has committed the funding as a bridge loan to help its anti-shingles cream through the initial stages of the regulatory approval process while it secures additional financing.

"Since the company has managed to scale down its cash expenditure rate to under $1.6 million per quarter, it is expected that this commitment will provide a substantial runway for the company," NanoViricides said in a release Tuesday morning.

The loan will be secured by a mortgage on NanoViricides' Shelton lab facility at 1 Controls Drive, the company said. About $1 million of the loan will be available immediately, and the remaining $1 million will be available in January or later if needed.

The company said it expects to complete additional financing soon through a secondary public offering of its common stock. 

In a quarterly earnings report filed last month with the U.S. Securities and Exchange Commission, NanoViricides reported a net loss of $1.56 million, or 41 cents a share, down from $1.84 million (53 cents a share) during the same quarter in 2018. The company reported no revenues, as is common with biotech companies that are still developing a commercial product.

The company said it had approximately $1.34 million in cash and cash equivalents and $1.43 million in liabilities as of Sept. 30.

NanoViricides said it has been “executing on all milestones toward the IND (investigational new drug) filing for its first clinical candidate along a reasonable projected timeline and is doing so with highly conservative expenditures.”

In a separate announcement, the company said it has initiated safety studies to support the FDA filing for the shingles drug, NV-HHV-101. It hopes eventually to develop treatments for cold sores and genital ulcers caused by the Herpes Simplex Virus using the same compound. 

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Shelton-based medical imaging company Sectra Inc. said Monday it has partnered with a German cancer diagnostics firm to pursue FDA clearance on a new digital pathology system.

Sectra is seeking approval for a system that would allow researchers and hospitals to view and store digital pathology images electronically, similar to what the company has been providing for years in radiology, a spokeswoman said.

The product is aimed at enterprise-level customers such as academic medical centers, clinical research organizations and large hospital networks. 

Germany-based Leica Biosystems is providing the scanner technology for the system, Sectra said. Leica’s Aperio AT2 DX is a high-throughput automated digital scanner that delivers diagnostic-quality whole slide images, according to the company.

Sectra said its digital pathology software will help streamline image access, review and diagnosis and facilitate deep integration with leading pathology information systems and electronic medical records.

An application for the combined system has been submitted to the FDA, Sectra said.

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New Haven’s BioXcel Therapeutics Inc. said Tuesday it will launch two Phase 3 clinical trials on its agitation drug for patients with schizophrenia and bipolar disorder by the end of this year.

Phase 3 studies are the final stage in the regulatory approval process for experimental drugs. 

The company said it has reached a general agreement with the FDA on the design of the studies, which will measure the change in symptoms of acute agitation compared to a placebo. 

The drug, BXCL501, is a dissolving, under-the-tongue formulation of the older FDA-approved drug dexmedetomidine (Dex).  BioXcel’s version is similar to a mouthwash strip.

BioXcel touts the drug as a potentially more effective, less invasive and easier to use therapy to calm agitated patients.

The two randomized, double-blind, placebo-controlled trials will enroll up to 750 patients ages 18 to 75. One study, called SERENITY I, will enroll patients with agitation associated with schizophrenia and the other, SERENITY II, will evaluate patients with agitation associated with bipolar disorder, the company said. 

Both studies will test the drug at doses of 120 and 180 micrograms against a placebo. 

Initial results are expected in mid-2020, the company said.

Contact Natalie Missakian at news@newhavenbiz.com

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