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30 Jun, 2022

Completed enrollment of patients for the iHand clinical trial

All 63 study participants have been recruited for the ongoing clinical trial with Carbonhand. The base line measurement for the last participant was conducted today and the study will be closed in the last week of September. The final results will be presented shortly after.

The primary objective of the study is to examine whether prolonged (six weeks) use of the assistive device Carbonhand during ADL at home results in a therapeutic effect in handgrip strength of the affected hand. Several interim analyses show promising results in handgrip strength and hand function. 

An interim analysis was presented at the joint congress of the International Federation of Societies for Surgery of the Hand and International Federation of Societies for Hand Therapy in London the 9th of June 2022. The Interim analysis, based on the results from 49 participants, show a significant improvement in both grip strength (27%) and hand function (12%)* at the end of the intervention period. Follow up measurements 4 weeks after the intervention period showed a 24% improvement in grip strength in relation to the base line level. A longer presentation with more details from the interim analysis will be presented at RehabWeek from July 25th to 29th in Rotterdam, the Netherlands.

”The preliminary results are very promising, and we are eager to be able to complete the trial and share the results, says Petter Bäckgren, CEO at Bioservo and continues, “a market assessment involving patients, clinicians and payers conducted early 2022 shows a strong need for Carbonhand, indicating that more than 30,000 patients in the United States alone are likely to receive reimbursement, equivalent to more than $250 million in turnover. We estimate that our focus markets within EU represents approximately the same potential.”

The clinical trial is a multicenter study conducted by Roessingh Research and Development and carried out by eight Dutch rehabilitation centers: Universitair Medisch Centrum Groningen (Groningen), Isala (Zwolle), Rijndam Revalidatie (Rotterdam), Reade (Amsterdam), De Hoogstraat Revalidatie (Utrecht), Sint Maartenskliniek (Nijmegen), Klimmendaal (Arnhem) and Roessingh Centrum voor Revalidatie (Enschede) in the Netherlands. The recruitment process for this clinical trial has been affected by the global pandemic in that it has taken longer to involve the number of study participants needed to obtain a reliable result.


For more information, please contact:
Petter Bäckgren, CEO
petter.backgren@bioservo.com
+46 8 21 17 10

Mikael Wester, Marketing Director
Mikael.wester@bioservo.com
+46 8 21 17 10


About Bioservo Technologies
Bioservo Technologies AB (publ) is a world leading company in wearable muscle strengthening systems for people in need of extra strength and endurance. All our innovative products and systems are designed to keep people strong, healthy, and efficient.

The company has a unique global position within soft exoskeleton technology for the hand, both for industrial applications to improve the health for workers and to improve quality of life for people with reduced muscle strength.

Bioservo Technologies was founded in 2006 in collaboration between researchers at the Royal Institute of Technology and a doctor at Karolinska University Hospital. Bioservo Technologies is a Swedish public limited company with headquarters in Stockholm.

FNCA Sweden AB, +46(0)8-52800399, info@fnca.se is the company’s Certified Adviser on Nasdaq First North

For more information, please visit www.bioservo.com
 

*Kottink AIR, Nikamp CDM, Buurke JH, Bos F, van der Sluis CK, van den Broek M, Onneweer B, Stolwijk-Swüste JM, Brink SM, Rietman JS, Prange-Lasonder GB. Carbonhand during ADL. IFSSH, IFSHT & FESSH Combined Congress. June 6-10 2022. ExCeL, London. The clinical trial has been conducted within the framework of the iHand project. The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 801945