If you’ve followed the robots space, you’re likely familiar with the research that has gone into these tiny, remote-controlled medical robots. Bionaut’s own work now has a couple of deadlines in place, including 2023 pre-clinical studies, followed by clinical trials with human patients the follow years.

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“There has been a dearth of innovation around treatments for conditions that cause tremendous suffering, in large part because past failures have discouraged even the best of researchers,” CEO and co-founder Michael Shpigelmacher says in a release. “Bionaut Labs remains committed to finding new ways to treat these devastating diseases, which are long overdue for a breakthrough.”

The startup’s magnetically driven robots of the same name are designed to deliver treatments to the midbrain — a more direct application than standard systemically delivered (intravenously, orally, etc.) drugs. The firm has its eyes on a number of extremely debilitating conditions, including Parkinson’s disease and Huntington’s disease.

This round of funding, meanwhile, will be focused on treatments for malignant glioma brain tumors and Dandy-Walker Syndrome. The money will also go toward advancing R&D on its technology and hitting the aforementioned milestones.

Shpigelmacher and co-founder Aviad Maizels were both previously involved with PrimeSense, the Israeli-based 3D imagining firm behind Microsoft Kinect. That firm was acquired by Apple in 2013 and ultimately served as the foundation for its Face ID tech.

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Geneva, Switzerland-based MedAlliance received FDA investigational device exemption (IDE) approval for its Selution SLR drug-eluting balloon in the below-the-knee procedures. One week later, the company enrolled the first patient in its multi-center FDA Selution4BTK trial in Germany.

The company designed Selution SLR (sustained limus release) with unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The micro-reservoirs provide a controlled and permanent release of the drug for up to 90 days, while MedAlliance’s CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.

“We are very excited to finally have drug-eluting technology in the US to treat this difficult patient population,” said the trial’s principal investigator Dr. Ehrin Armstrong. “We are encouraged by the positive early outcomes with this novel Selution SLR sirolimus drug-eluting balloon (DEB) in Europe and Asia. We hope this FDA IDE trial will demonstrate significant benefit for patients who currently have limited treatment options.”

The company said in a news release that the aim of the prospective, multi-center, single-blinded, randomized trial is to demonstrate the superior efficacy and equivalent safety of Selution SLR compared to plain (uncoated) balloon angioplasty (POBA) in the treatment of BTK arteries in chronic limb-threatening ischemia (CLTI) patients.

In total, 377 subjects will be randomized 1:1 to Selution SLR or control. MedAlliance said it represents the first study of its kind in which real-world patients with CLTI can be included.

Patients will be enrolled across approximately 40 sites in the U.S., Europe and Asia. The first U.S. patient was enrolled at Vascular Solutions in Cary, North Carolina by Dr. Siddhartha Rao.

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“We are very pleased to be participating in this groundbreaking study,” Rao said. “We hope that this promising technology will fulfill a huge need for our patients with chronic limb-threatening ischemia, saving life and limb. We look forward to the rapid enrolment of this trial.”

Selution SLR holds CE mark approval for treating peripheral artery disease and for treating coronary artery disease. It has four FDA breakthrough device designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-Fistula indications.

“We were the first company to be granted “breakthrough device designation” for a DEB by the FDA and are proud to enrol the very first U.S. patient in a sirolimus DEB study” said Jeffrey B. Jump, MedAlliance Chair and CEO.  “Many companies have been trying for years to bring sirolimus to the US and we are very pleased with our team for achieving this significant milestone. U.S. patients will now have an alternative to paclitaxel DEB, addressing the concerns expressed by the FDA.”

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Formed at the University of California, Berkeley, NovaXS designed its patent-pending Telosis technology to administer a narrow stream of medication without a needle in 0.3 seconds and to analyze injection data to allow for smarter health decisions.

The company said in a news release that its technology represents the world’s first remote medication and self-administration monitoring platform as an easy and painless alternative for at-home drug delivery. The first indication being pursued by NovaXS is IVF treatments.

NovaXS presented its prototype at mHub’s MedTech Accelerator Program’s annual Demo Day in Chicago last week. COO and co-founder Jonathan Xing also shared the company’s plans for product development, market potential and revenue generation at the event, while highlighting milestones including submitting the new prototype for a patent and signing multiple letters of intent with IVF clinics in California.

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The company was selected among hundreds of applicants based on its ability to address large, unmet needs with innovative solutions that will transform patient care, the company said.

“NovaXS’ team has been working hard to develop a user-friendly no-needle solution for injection drug delivery. We envision a day when people living with chronic illness have one less thing to worry about because all they have to do to administer their medication is press one button and their healthcare provider can remotely monitor their treatment,” Xing said. “mHub’s accelerator program has given NovaXS the tools and resources we need to focus on product development and has provided opportunities for us to connect with new investors and industry partners.”

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LBO France, a private equity player, led the financing round, while Terumo — with which Diabeloop has partnered since 2020 — also participated in the round.

Innovacom joined LBO France and Terumo as new investors, according to a news release. Previous investors CERITD, CEMAG Invest, Kreaxi, Supernova Invest, AGIR A DOM., Crédit Agricole, Odyssée Venture, UI Inventissement (Sofimac) and Promontoires all elected to reinvest, Diabeloop said, while Bpifrance and the historical bank pool support the company via debt financing.

Paris-based Diabeloop develops machine learning software for diabetes treatment. Its algorithms are integrated into easy-to-use products to facilitate chronic disease management.

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The company has commercialized closed-loop solutions for personalized management for type 1 diabetes and highly unstable type 1 diabetes, connecting a continuous glucose monitor (CGM) and insulin pump for insulin therapy with the algorithms analyzing data in real-time and providing automated insulin delivery.

“Being able in 2021 to bring the benefits of our products to thousands of patients and hearing their enthusiasm, is why all of us at Diabeloop work so hard,” Diabeloop founder and CEO Erik Huneker said in the release. “The financing round announced recognizes the team’s successes, and more importantly, the great opportunities ahead.”

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Paris-based Diabeloop’s real-life German cohort data, presented at the Advanced Technologies & Treatments for Diabetes (ATTD) Conference in Barcelona, show a constant improvement in time in range (70-180 mg/dL) combined with a significant reduction of hypoglycemia.

According to a news release, the 974-patient cohort demonstrated an increase of 18.4% in time in range, an improvement associated with better glucose control, fewer complications and improved quality of life in patients with type 1 diabetes. The company said the performance confirms Diabeloop’s platform’s ability to improve glycemic control in the real-life environment, which is less controlled than in hospital-supervised studies.

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DBLG1 also demonstrated a significant reduction in time spent in hypoglycemia, with users whose HbA1c was available at initiation spending just 0.9% of the time below 70 mg/dL and 0.1% of the time below 54 mg/dL5.

The company said the hypoglycemia data shows that DBLg1 contributes to the reduction in risks such as discomfort, dizziness and even life-threatening situations.

“It is a great satisfaction to see that these new data extracted from an even larger cohort of patients show a simultaneous performance on TIR and reduction of hypoglycemia,” Diabeloop CEO and co-founder Erik Huneker said in the release. “Combined with the positive and very concrete feedback from the people equipped, this motivates us to go even further, to address more and more populations affected by diabetes.”

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The San Jose, Calif.–based company’s IPO of 6.7 million shares priced at $11 a share, generating gross proceeds of $73.3 million.

The company initially targeted an IPO worth approximately $100 million, with shares trading between $14 and $16.

The company has developed a proprietary platform designed to provide a pill-based alternative to intravenous or subcutaneous administration of biologics. The robotic pill deploys its payload of proteins, peptides or antibodies when it reaches the intestine.

In a Phase 1 trial, the company demonstrated the absorption of a biologic on the order of 65%. “That’s in line with subcutaneous injections, which ranged between 40% and 80%,” said Talat Imran, the company’s CEO. “Based on that and our plans for the rest of the drugs in our pipeline, we felt like it was the right time to go public.”

That study involved Octreotide, a treatment that can reduce excessive growth hormone levels and treat diarrhea linked to some tumors.

The technology is “a robotic pill, but it’s like a chemistry-based robot,” Imran said. Resembling a capsule, albeit larger in size, the robotic capsule has a pH-sensitive coating. The coating keeps the capsule intact as it passes through the stomach when it gets to the small intestines. “When it arrives there, the capsule dissolves and expands a balloon,” Imran said. That occurs as a result of a reaction that is “akin to Alka Seltzer, which produces CO2 gas.” The expansion plays a role in inserting a needle into the intestinal wall.

“There are no sharp pain receptors in the gut,” Imran added. “In our Phase 1, we were able to determine that the patients who were dosed with Rani pills had no sensation or perception when the injection occurred.”

RaniPills

The company has conducted preclinical research on TNFα inhibitors, parathyroid hormone, human growth hormone, GLP-1 and basal insulin.

The appeal of a pill-based alternative to injectables could be especially great for patients on daily subcutaneous medicines such as teriparatide, an osteoporosis treatment often administered daily. The burden of injections limits the therapeutic potential of drugs like teriparatide, Imran said. “We believe that going to an oral formulation could provide more patients with the opportunity to take this medication,” he noted.

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Lucerne, Switzerland/Marlborough, Mass.-based CeQur said in a news release that it plans to use the funds to advance the commercial plans for the CeQur Simplicity wearable insulin delivery device. The company’s plans include market development, a phased commercial launch with a limited market release in 2021 and the scale-up of high-volume manufacturing.

CeQur Simplicity, which is FDA-cleared and has CE mark approval, is a three-day, wearable insulin device designed to discreetly and conveniently provide bolus dosing without an injection. One Simplicity patch holds up to 200 units of rapid-acting insulin administered in two-unit increments and replaces, on average, nine mealtime injections over three days, according to a news release.

The company touts clinical research that demonstrates that 90% of CeQur Simplicity users reported following their insulin regimen better when compared to multiple daily injections. The device is clinically proven to improve glycemic control, CeQur said.

Credit Suisse Entrepreneur Capital Ltd. and Endeavour Vision led the financing with significant participation from new investors, including Tandem Diabetes Care, Ypsomed Group, Federated Hermes Kaufmann Funds, Kingdon Capital, and GMS Capital, along with existing investors, Schroder & Co. Bank SA and VI Partners.

“We are grateful for the support from this group of world-class investors, who share our vision to transform the lives of people with diabetes who require daily insulin therapy. In the pilot launch of CeQur Simplicity, we’ve been very encouraged by the feedback from healthcare professionals, payers and people with diabetes, which validates that this novel device offers meaningful benefits to a large segment of people who are insulin-dependent,” CeQur president & CEO Bradley Paddock said in the release. “We look forward to advancing our commercial and manufacturing plans in preparation for our broadscale launch.”

That Tandem Diabetes Care, itself a developer of an industry-leading closed-loop insulin delivery system, invested in the financing highlights the potential impact of CeQur Simplicity in the diabetes management space, according to the company.

“CeQur Simplicity is designed to address a large, underserved segment of the diabetes market by providing a simple, low-profile and comfortable alternative to injections,” Tandem president & CEO John Sheridan said. “We recognize that there is not a one-size-fits-all solution for people living with diabetes, and this investment aligns with our goal to advance diabetes care by expanding the set of tools available to provide customer choice and ensure optimal therapeutic outcomes.”

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