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Seraccess® ONE - Breakthrough wearable Artificial Pancreas Device System for patients suffering from severe glycemic dysregulation

 

Fully automated, wearable closed-loop APDS for highly accurate and precise blood-glucose monitoring and control for the diabetes patients who need it most. Seraccess® ONE is semi-miniaturized wearable which operates with a commercially available standard catheter.

Brittle diabetes describes a group of diabetes patients suffering from life-changing disruptions due to severe glycemic dysregulation, indicating a condition of instability of glycemic control requiring frequent hospitalizations and causing impaired quality of life and enormous economic cost. These patients are at risk for many unfortunate consequences: poor glycemic control with its complications, more emergency room and hospital admissions, strains on relationships, and greater healthcare utilization and diabetes distress. Current standard of care cannot significantly help these patients, they spend very little time within the target blood glucose range.1 Brittle diabetes is characterized by severe instability of blood glucose levels with frequent and unpredictable episodes of hypoglycemia often requiring hospitalization. Hypoglycemia unawareness is one of the hallmarks of brittle T1D. Hypoglycemia unawareness is especially dangerous because the hypoglycemic individual will not know to take corrective action to prevent further deterioration. If left untreated, hypoglycemia may become severe, resulting in confusion, disorientation, loss of consciousness, or, in extreme cases of prolonged hypoglycemia, permanent brain damage or death.2 Equally dangerous are pronounced and prolonged hyperglycemias, which can lead to diabetic ketoacidosis (DKA) and associated frequent hospitalizations.

Secondary complications, including neuropathy, cardiovascular disease, and retinopathy can be especially common in brittle T1D and there is a significant excess mortality in these patients despite intensive insulin therapy.3 A twenty-year outcome study showed a shockingly 50% mortality rate in a group of women with a mean age of 42 years. In a normal non-brittle type 1 diabetes population, the expected death rate over such a period would be about 5%.4,5

 

Why Seraccess® ONE?

 

Seraccess® ONE is a wearable device which operates nearly in real time and in direct communication with the patient's bloodstream. The nearly delay-free, highly accurate and precise blood-glucose measurement allows to administer the exact amount of insulin needed - via a commercially available standard catheter - directly into the bloodstream to manage blood glucose within the target range. An increase in time in range translates directly into a reduction of short- as well as long-term complications. Seraccess® ONE is a fast acting closed-loop control system which can revolutionize therapy in this patient group.

 
 
 

The Seraccess® ONE Approach

 

The automated, regular, accurate and precise glucose measurement provided by Seraccess® ONE allows to deliver the necessary amount of insulin directly into the blood where it immediately unfolds its effect. Blood glucose can be controlled within the real physiological target range which can lead to significantly improved clinical outcomes.

 
Blood glucose monitoringBlood samplingPlasma extraction
 

How much blood is needed per day to measure blood glucose every 15 minutes?

The Seraccess® technology only needs 20µl to 30µl of blood to perform a measurement. At a frequency of 15 minutes, this results in 96 measurements per day which amounts to just 2ml to 3ml of blood needed per day.

blood-sampling
 
 

Opportunity

 

Brittle diabetes affects at least 3 in 1'000 insulin-dependent patients which translates to at least 26'000 patients in the US alone.6,7,8 The Brittle Diabetes Foundation uses glycemic variability (of 36% or more) to distinguish between brittle and stable type 1 diabetes and estimates 70'000 affected patients in the US alone.9 These patients suffer from recurrent DKA episodes resulting in multiple hospital admissions every year, with average costs of 30'000 USD per DKA admission.10 There were 189'000 hospital admissions for DKA in 2014, generating costs of 5.1 bn. USD6 It is estimated that hospital admissions for DKA in 2021 have grown to more than 200'000, generating costs of about 6 bn. USD. On average, brittle diabetes patients account for 8 hospital admissions for DKA per year4, generating costs of around 240'000 USD per patient, despite the use of current state-of-the-art diabetes technology. Applying an annual flat fee per patient approach, market value is estimated to be at least 2 bn. USD.

 
 

Milestones

 

The benefits of the intravenous pathway - Part I

Improving Time-in-Range not only in the STRECHTED RANGE (70-180mg/dl), but also in the HEALTHY RANGE (70-140mg/dl)?

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The benefits of the intravenous pathway - Part II

Does measurement delay have a negative impact on Time-in-Range (70-140mg/dl)?

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The benefits of the intravenous pathway - Part III

How does the Seraccess® blood glucose measurement perform in healthy subjects when compared to Cobas C111?

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The benefits of the intravenous pathway - Part IV

How does the Seraccess® blood glucose measurement compare to state-of-the-art CGM?

The benefits of the intravenous pathway - Part V

How does the Seraccess® blood glucose measurement perform in healthy subjects when compared to YSI?

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The benefits of the intravenous pathway - Part VI

How does the Seraccess® blood glucose measurement perform in subjects with type 1 diabetes when compared to Cobas C111?

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Seraccess® is a mid-stage venture project of Securecell that offers investment opportunities to private and institutional investors.

All information and opinions contained herein have been prepared by management and its advisors and represent their assessment as of January 2022. No representation or warranty, expressed or implied, is given as to the accuracy or completeness of the contents, opinions, or projections expressed herein and no responsibility or liability is accepted. All information videos and contents do not constitute an offer to purchase securities. The website content does not constitute an invitation to buy shares under US or international law.

References:

1 I.B. Hirsch, L.M. Gaudiani: A new look at brittle diabetes. Journal of Diabetes and Its Complications 35 (2021) 107646; https://doi.org/10.1016/j.jdiacomp.2020.107646
2 Cryer, P.E., S.N. Davis, and H. Shamoon, Hypoglycemia in diabetes. Diabetes Care, 2003. 26(6): p. 1902-12.
3 Lind, M., et al., Glycemic control and excess mortality in type 1 diabetes. N Engl J Med, 2014. 371(21): p. 1972-82.
4 Cartwright A. et al. The outcome of brittle type 1 diabetes - a 20 year study. Q J Med 2011; 104:575-579
5 Flanagan D. What happens to people with “brittle” diabetes? Diabetes Digest 2011 Vol 10;4:196 https://www.pcdsociety.org/download/resource/2756; accessed Dec 16, 2021
6 https://www.webmd.com/diabetes/brittle-diabetes-all-about; accessed Dec 15, 2021
7 CDC National Diabetes Statistics Report 2020; https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf; accessed Dec 15, 2021
8 https://www.americanactionforum.org/research/understanding-the-insulin-market/; accessed Dec 15, 2021
9 https://www.bdtype1.com/difference-stable-type-1-vs-brittle, accessed Dec 20, 2021
10 Lyerla et al. Recurrent DKA results in high societal costs - a retrospective study identifying social predictors of recurrence for potential future intervention. Clin Diabetes Endocrinol (2021) 7:13; https://clindiabetesendo.biomedcentral.com/track/pdf/10.1186/s40842-021-00127-6.pdf