How can I make a donation to Beta Bionics?
Beta Bionics is a private, for profit, public benefit corporation. If you are seeking to make a donation, we suggest donating to a non-profit organization that supports the type 1 diabetes community.
I invested via Wefunder and would like to know how my investment is doing?
We are working very hard at Beta Bionics to bring our technology through regulatory approval and available to people with type 1 diabetes. You can follow our development work on our web site and via social media.
Can I sell my shares in Beta Bionics?
Privately held shares in Beta Bionics are not liquid or tradeable on any public stock exchange at this time. Additionally, Beta Bionics shares are not tradeable privately at this time. While this may change in the future, there are no currently available avenues through which to liquidate an investment in Beta Bionics.
When will shares be available for purchase?
At this time, there are no Beta Bionics shares available for purchase on any stock exchange or by any private means. We are very pleased to have strong institutional investor support to complement our 2016 Reg CF investor community. While the Reg CF was a fundraising strategy the company utilized early on, we do not foresee any future share offerings via Regulation Crowdfunding.
When do you anticipate the iLet® bionic pancreas will be available for sale in the US?
We are working diligently to bring the commercial version of the iLet to market. A phase 3 clinical trial is being initiated this year (refer to clinicaltrials.gov, study # NCT04200313) to test the iLet bionic pancreas in adults and children with type 1 diabetes (6 years or older). Screening of subjects for enrollment into this trial has already taken place at 16 clinical sites across the US. The study is expected to take about 9 months to complete (of course, this timeline could be impacted by COVID or other factors). Results from this clinical trial will support our application to the FDA for regulatory clearance of the insulin-only configuration of the device in that population. Once the FDA application is filed, FDA review of 510(k) market applications typically take up to 6 months.
We anticipate that our bihormonal pivotal trial will begin sometime following the completion of the insulin-only pivotal trial. If the results of the trial are favorable, we expect to receive FDA clearance of the bihormonal iLet approximately 12 to 24 months after clearance of the insulin-only configuration of the iLet. That timeline is largely determined by the length of the clinical trial and regulatory review process required for dasiglucagon.
How do I become involved with clinical trials testing the iLet?
At present, the iLet bionic pancreas is only available to patients who participate in clinical trials testing our investigational devices. The clinical sites in charge of each clinical trial are responsible for deciding who may be eligible to participate in a clinical trial. Beta Bionics is not involved in patient recruitment and is unable to advise people about their medical condition or appropriate treatment. People who are interested in enrolling in clinical trials testing our technologies should discuss their interest with their health care provider, who can then refer them to the clinical trial sites, if appropriate. Links to general information about ongoing clinical trials are provided under the Ongoing Clinical Trials tab of our website.
Will the iLet be approved for children?
Our expectation is to test and ultimately seek clearance of the iLet bionic pancreas in all age-ranges. So far, the bionic pancreas technology has been tested in people with T1D 6 to 78 years of age in outpatient, summer camp, and home-use settings and has shown clinical success across this entire age-spectrum.
What about stable glucagon?
Until recently, the poor stability of the currently available human glucagon formulations meant that the rescue glucagon kits that we used had to be freshly reconstituted every day in all of our clinical trials testing the bionic pancreas algorithms. Stable glucagon was one of the missing pieces we needed in order to make the bihormonal bionic pancreas technology a practical solution. On June 22, 2017, Zealand Pharma announced the results of its Phase 2A study demonstrating the feasibility of dasiglucagon, a glucagon analog, as a replacement for unstable human glucagon when administered automatically using the bionic pancreas algorithms. The study was conducted at the Massachusetts General Hospital Diabetes Research Center in Boston, MA, USA, with Steven J. Russell, MD, as Principal Investigator. This trial, along with the pharmacokinetic and pharmacodynamic data from Zealand’s recently completed dasiglucagon micro dose trial, provides the foundation for further clinical development of dasiglucagon in the iLet.
For more information on the progress Zealand Pharma is making on dasiglucagon please visit: https://www.zealandpharma.com/dasiglucagon-pump
Will the iLet be available outside the U.S.?
We are working as quickly as possible to bring the iLet to market. While we are currently focusing our resources on achieving FDA clearance of the iLet in the U.S., our goal as a public benefit corporation and a Certified B Corporation is to make our technology available and accessible to as many people as possible across the globe. In that spirit, we are taking deliberate steps to bring the iLet to countries outside the U.S.; however, regulatory clearance and reimbursement considerations in different markets depend upon many factors, so timelines for international availability have not yet been determined.
Will the iLet be covered by insurance?
This is ultimately dictated by the insurance companies and government payers. However, we certainly are working to generate a large data set, through rigorous clinical trials designed to test the system in real-world settings. We hope that these data will be compelling to insurance companies and government payers, and will convince them to provide coverage for the iLet bionic pancreas — once it is cleared by the FDA — for as many patients as possible.
How can I stay updated on the progress you are making?
Please use our contact form and indicate you would like to be added to our mailing list. You can also check our Facebook page here for regular updates.
How can I invest in Beta Bionics?
Beta Bionics is not currently seeking private investment and does not broadly solicit individual investment.