FDA Approves New Tubeless Insulin Pump by Miriam Tucker for MedScape.com, 23 August 2023.
The US Food and Drug Administration (FDA) has granted clearance for Roche’s Accu-Chek Solo micropump system, a tubing-free “patch” pump for people with diabetes who use insulin. The product received CE Mark in Europe in 2018 and is now available in 19 markets worldwide. It offers users a choice of bolusing directly from the pump or from a handheld remote-control device. The pump can be detached and reattached without wasting insulin. The remote-control device also incorporates blood glucose monitoring and bolus advice, although it currently does not integrate with continuous glucose monitoring (CGM) devices.
Altucell Advances First-Ever Regulatory-Approved Human Islet Cell Encapsulation Therapy for Type 1 Diabetes by Praveen for BusinessNewsThisWeek.com, 23 August 2023.
Altucell Therapeutics is making monumental advancements in the realm of diabetes care. The company remains at the forefront of groundbreaking research and it is currently engaged in human pilot studies with encapsulated human pancreatic islet transplantation for patients affected by type 1 diabetes mellitus. Altucell utilizes its signature platform encapsulation technology (AltuCaps), with the goal of negating the need for immunosuppressants.The company, using its cutting-edge encapsulation technology, AltuCaps, aims to replace traditional treatments and avoid the need for immunosuppressants. Additionally, they have a full pipeline of cell lines designed to address major diseases more effectively than current interventions.
This advancement is just one of many that Altucell has to offer. Born from the CEO’s personal journey – after Gary Harlem’s son was diagnosed with type 1 diabetes – Altucell has swiftly transformed into a biotech titan, specializing in cell-based therapies. Their unwavering mission is to provide cures for diabetes and other autoimmune conditions using next-generation cell-based biologics.
Exosomes: Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells. In recent years, exosomes have gained attention as a strategy for accessing the therapeutic effects of cells without the risks and difficulties of administering the cells to patients.
Abata Therapeutics Announces 2nd Development Candidate, a Novel Treg Cell Therapy for the Treatment of Type 1 Diabetes published by BioSpace.com, 24 August 2023.
Abata Therapeutics, a company focused on translating the biology of regulatory T cells (Tregs) into transformational medicines for patients living with severe autoimmune and inflammatory diseases, announced its second development candidate, ABA-201, which has the potential to be a disease-modifying Treg cell therapy for patients with type 1 diabetes (T1D) who have remaining beta (β) cell function.
Results from preclinical models of insulitis, such as the nonobese diabetic (NOD) mouse, and clinical trials testing either immunomodulators or polyclonal Tregs in patients with at-risk or new-onset T1D, reinforce the possibility that autoantigen-specific Tregs can have a highly potent therapeutic effect in T1D. Additional non-clinical studies have established the role of Tregs in suppressing β-cell injury, a further potential benefit of the approach.
“ABA-201 is a Treg cell therapy that uses a TCR (T-cell Receptor) to target the pancreas and draining lymph nodes in patients with T1D to limit ongoing β-cell destruction and preserve residual β-cell mass, with the added potential to promote repair of damaged tissue and establish long-lived tissue residency. Suppressing T cell function has been shown to delay T1D onset. We believe our targeted approach to suppressing pancreatic islet-associated inflammation could offer significant and long-lasting clinical benefit to patients,” said Leonard Dragone, M.D., Ph.D., chief medical officer of Abata. “This second program expands the scope of our pioneering Treg cell-based approach to patients with T1D. As someone who has spent much of my career caring for patients and working to treat autoimmune diseases, I’m truly excited to see what these candidates can do for patients.”
Dexcom, Abbott ramp up DTC marketing amid fight for share of growing diabetes market by Elise Reuter for MedTechDive.com, 17 August 2023.
The wearable devices, which replace fingersticks for people with diabetes to monitor their blood sugar, are expected to increase in sales as more insurers pay for them. In April, Medicare expanded coverage of the devices for more people with Type 2 diabetes, a decision that “represented the largest single expansion of access to CGM in our industry’s history,” Dexcom CEO Kevin Sayer said.
Chicago-based Abbott Laboratories and San Diego-based Dexcom, which are the top two sellers of continuous glucose monitors, are competing for their slice of the global market for diabetes technology. That battle has moved onto people’s TV screens, into magazine ads, and online, as both companies seek to reach millions more potential customers.
Currently, CGMs make up a $4 billion market in the U.S. That market could expand to $10 billion in 2025, assuming more people with Type 2 diabetes who take daily injections of long-acting basal insulin or who don’t take insulin at all start wearing the devices. To get there, medical device companies are taking a similar approach to the pharma ads that tell patients to ask their doctors for a prescription.
Emerging Players in Diabetes Tech: Small but Impactful by Dr. Inge van Boxelaer for Diabotech.com, 24 August 2024.
The field of diabetes technology is undergoing rapid transformation, marked by a flurry of groundbreaking partnerships, novel applications, and cutting-edge closed-loop systems. Here, we will delve into the world of emerging players in this dynamic field, spotlighting companies such as Tidepool Loop, Modular Medical, SFC Fluidics, Pharmasens, and OneTwenty.
- Tidepool Loop Partners with new Insulin Pump for T2D of Embecta:
Embecta is developing an ACE pump and their goal is to deliver a version of Tidepool Loop for the type 2 diabetes community so we’re super excited about that because it really brings the technology that you know in Loop in a much broader and more accessible form.” – Howard Loop, CEO Tidepool, Interview Diabetech July 2023 Tidepool Loop is Tidepool’s version on the open-source do-it-yourself Loop closed-loop system, with an onboarding feature to help people learn about Loop; with steps to improve safety and quality, and as of January 2023, Tidepool Loop is the first-ever FDA-approved interoperable Automatic Glycemic Controller (iAGC), which essentially means it is an app that can talk to multiple devices.
- Expanding Accessibility: Tidepool Loop for Android Devices:
An anonymous donor has stepped forward with a generous grant that’s set to propel Tidepool Loop onto Android devices. While the specifics of which Android phones and even watches it’ll be compatible with are still under exploration, the team is determined to make it a seamless experience for users. This development comes at a crucial time, with the acknowledgment that Android stands as the most popular mobile platform globally, accounting for around 70% of users worldwide.
- Innovative Collaboration for Insulin Delivery: Modular Medical and Philips-Medisize:
A new partnership is on the horizon as Modular Medical, a company dedicated to advancing insulin delivery technology, joins forces with Philips-Medisize. This dynamic duo is set to pave the way for the MODD1 Insulin Delivery System, an innovative solution that promises user-friendliness and affordability.
- SFC Fluidics receives grant to develop Gemini Dual Hormone Artificial Pancreas Pod:
US-based SFC Fluidics is the brains behind the Panda pump. Their dedicated efforts have been recognized through the award of a substantial $2 million Small Business Innovation Research (SBIR) Phase II grant. (press release July 20th, 2023). This grant is set to propel the advanced development of SFC’s Gemini™ Dual Hormone Artificial Pancreas Pod (Gemini-DHAP):
- With this financial boost, SFC Fluidics is poised to obtain an Investigational Device Exemption (IDE) for its Insulin and Glucagon delivery system.
- This IDE will pave the way for initiating clinical trials, a crucial step towards securing FDA approval for their groundbreaking technology.
- Introducing the Niia Pump by PharmaSens: A Glimpse into Innovative Diabetes Technology:
PharmaSens, a pioneering diabetes technology company based in Switzerland, showcased at ATTD2023 and participated in the ADA 2023 technology fair, with a sneak peek into their innovative creation, the niia essential insulin pump. PharmaSens is preparing to seek FDA approval for the niia essential system in 2023.
- This new patch pump is “semi-reusable” and holds up to 300 units of insulin.
- Although currently wearable for up to three days, PharmaSens envisions stretching this wear time in the future.
- It has a bolus button for easy dosing, and you can fill and start the pump without needing a syringe or separate inserter.
- This user-friendly patch pump is particularly designed for individuals who presently manage their diabetes through multiple daily injections (MDI).
- Video on Filling Insulin into Niia Pump
- Elevating Closed-Loop Algorithms with Digital Twin Innovation: OneTwenty’s Breakthrough:
Introducing OneTwenty, a relatively new entrant to the scene, having emerged in 2022 with a distinct focus on pioneering digital twin algorithms. Their closed-loop algorithm achieved an impressive Time in Range (TIR) of 90% within a diverse diabetes population, validated extensively using the FDA-approved UVA simulator in a wide range of realistic scenarios. OneTwenty’s approach integrates the algorithm within the microchip of the insulin pump to enable maximum autonomy for the user. The company is currently immersed in dialogues with potential pump partners, although the precise details of these collaborations remain confidential at this stage.
They’ve developed an advanced closed-loop algorithm (medicAID) that has the potential to be taken to new heights through the integration of digital twin technology (BioX® neoAP).OneTwenty is steering innovation in more directions:
- bioX® sensAI is an additional digital twin algorithm that transforms raw sensor data into heightened accuracy. This has the potential to enhance the precision of (non-invasive) Continuous Glucose Monitors (CGMs).
- Delving into web-based digital twin technology, OneTwenty is crafting Newton i/O – a web platform geared towards analyzing CGM and insulin pump data. Operating somewhat like an Autotune, it aims to provide insights for individuals as well as healthcare providers and data-driven recommendations for basal insulin rates. A clinical study to validate this decision support software is slated for 2024.
Insulet: Losing More Weight, by The Value Investor on SeekingAlpha.com, 24 August 2023.
In June, The Value Investor noted that margins of Insulet Corporation were on a diet. The company was looking to revolutionize the diabetes market, and while the company has seen strong commercial traction (driven by the Omnipod 5), operating leverage was still a bit hard to find. With expectations still high, I refrained from getting involved despite the potential of the business.
Fast forwarding two months in time, shares have fallen another 30% despite a solid second-quarter earnings report, amidst high valuations from the start and real concerns related to increased competitive threats, even from non-direct competitors.
Read more: Insulet: Losing More Weight
Medtronic plc Q1 2024 Earnings Call Transcript posted on SeekingAlpha.com, 22 August 2023.
Slide Deck: Medtronic plc Q1 FY24 Earnings presentation