Sana Biotechnology Announces Positive Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression released by Sana.com, 7 January 2025.
Sana Biotechnology, Inc., a company focused on changing the possible for patients through engineered cells, announced initial results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana’s hypoimmune (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression. The study was conducted in partnership with Uppsala University Hospital. Results of the study at four weeks after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. MRI scanning also demonstrated a sustained signal at the site of transplanted cells over time, which is consistent with graft survival. The study identified no safety issues, and the HIP-modified islet cells evaded immune responses.
“These initial exciting results build upon the extensive preclinical and translational studies of Dr. Sonja Schrepfer and the team at Sana. The clinical data are highly promising for patients and provide the first evidence in humans for overcoming allogeneic and autoimmune rejection with pancreatic islet cell transplantation in type 1 diabetes with no immunosuppression,” said Per-Ola Carlsson, MD, Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. “In type 1 diabetes, a person’s immune system attacks and destroys the beta cells. Today’s data, when combined with progress elsewhere in the field, provide real hope that a scalable, curative treatment for patients with type 1 diabetes, meaning normal blood glucose with no insulin injections or immunosuppression, is possible. We look forward to longer follow-up and plan to submit study results for publication as well as for presentation at an upcoming scientific forum.”
“We achieved our goals for the study, identifying no safety issues as well as demonstrating survival, function, and evasion of immune detection of HIP-modified primary pancreatic islet cells transplanted intramuscularly with no immunosuppression,” said Steve Harr, Sana’s President and Chief Executive Officer. “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune-competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases.
Beta Bionics, maker of ‘bionic pancreas,’ files for IPO by Elise Reuter for MedTechDive.com, 8 January 2025.
Beta Bionics, developer of an automated insulin delivery system, filed for an initial public offering. The company did not disclose the number of shares it will offer or the price range. Beta Bionics plans to list its shares on the Nasdaq under the ticker symbol “BBNX.” The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, cleared by the Food and Drug Administration in 2023. Beta Bionics plans to use the proceeds to grow its sales and manufacturing infrastructure and develop new features for its device.
According to the filing with the Securities and Exchange Commission, the diabetes tech company reported revenue of $44.7 million and a net loss of $36.6 million for the nine months ending September 2024. As of that date, Beta Bionics had an installed customer base of 11,214 people.
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Glooko and Hedia launch joint diabetes management solution posted by GlobalData.com, 8 January 2025.
Glooko and Danish digital therapeutics company Hedia have launched their combined diabetes care technology provision in the UK to enhance support for diabetic patients who require bolus insulin dosing support in their daily management. Glooko’s platform enables patients to share diabetes data, including blood glucose readings, insulin doses, and blood pressure with their healthcare providers.
First announced in April 2023, the integration with Hedia Diabetes Assistant allows patients using Glooko’s platform to gain personalized support in calculating insulin doses, which Glooko stated would simplify their diabetes management and support more consistent blood glucose levels. Glooko CEO Mike Alvarez said: “We are very pleased to bring this algorithm-driven, personalized innovation to diabetes patients and their healthcare teams through our partnership with Hedia.
“With extensive clinical data supporting Hedia’s efficacy, this solution provides an alternative for those unable to access insulin pumps, ensuring more effective management of MDI [multiple daily injection] therapy.” Now available in the UK, the companies plan to roll out their offering in other European countries at a later date.
Read more: Glooko and Hedia launch joint diabetes management solution
CeQur raises $120m to advance wearable insulin patch commercialization published by GlobalData.com, 8 January 2025.
Switzerland-based CeQur has completed a $120m equity financing round to support the ongoing commercialization efforts for its CeQur Simplicity insulin delivery device. The company stated that since its pilot market launch in April 2021, more than 6,000 diabetes patients are now using the device, which comprises a wearable insulin delivery patch for injection-free bolus dosing. CeQur plans to put the latest funding towards scaling its commercial teams and outreach initiatives to bring CeQur Simplicity to more healthcare providers and patients.
In June 2024, the device gained 510(k) clearance from the US Food and Drug Administration (FDA) for an extended wear duration from three to four days – a development the company said would replace up to 12 injections for simplified mealtime insulin management and result in more than 1,000 fewer injections annually.
CeQur president and CEO Brad Paddock commented: “We are grateful for the support of our investors as we accelerate our mission to transform diabetes care.”
Read more: CeQur raises $120m to advance wearable insulin patch commercialization
New glucose monitoring method could revolutionize diabetes management by eliminating finger-sticks for blood samples published by Binghamton University on Eurekalert.org, 9 January 2025.
Adapting the knowledge that Professor Seokheun “Sean” Choi’s Bioelectronics and Microsystems Lab has gained about biobatteries over the past 15 years, the new paper-based biosensor system uses Bacillus subtilis bacterial spores that germinate in response to glucose in potassium-rich bodily fluids, such as sweat. The amount of power generated would determine the glucose level.
Choi, Assistant Professor Anwar Elhadad, PhD ’24, and PhD student Yang “Lexi” Gao from the Thomas J. Watson College of Engineering and Applied Science’s Department of Electrical and Computer Engineering recently published their findings in the journal Microsystems & Nanoengineering. The research is supported by two grants from the National Science Foundation.
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New rule wipes medical debt from consumer credit reports by Susanna Vogel for HealthCareDive.com, 8 January 2025.
On the way out the door, the Biden administration finalized a rule that removes medical debt from consumer credit reports and bars lenders from using medical information in lending decisions. The rule will remove an estimated $49 billion of medical debt from approximately 15 million Americans’ credit reports, raising impacted consumers’ credit scores by an average of 20 points, according to Vice President Kamala Harris, who announced the final rule Tuesday.
The administration has also directed states and localities to use American Rescue Plan funds for medical debt relief. Harris said the funds have already been used to erase over $1 billion in debt and are tracking toward eliminating $15 billion of medical debt.
Read more: New rule wipes medical debt from consumer credit reports
Morning coffee may protect the heart better than all-day coffee drinking published by the European Society of Cardiology for MedicalXpress.com, 7 January 2025.
People who drink coffee in the morning have a lower risk of dying from cardiovascular disease and a lower overall mortality risk compared to all-day coffee drinkers, according to research published in the European Heart Journal.
The research was led by Dr. Lu Qi, HCA Regents Distinguished Chair and Professor at the Celia Scott Weatherhead School of Public Health and Tropical Medicine at Tulane University, New Orleans, U.S.
He said, “Research so far suggests that drinking coffee doesn’t raise the risk of cardiovascular disease, and it seems to lower the risk of some chronic diseases, such as type 2 diabetes. Given the effects that caffeine has on our bodies, we wanted to see if the time of day when you drink coffee has any impact on heart health.”
Read more: Morning coffee may protect the heart better
