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LIFE – Longevity trial: Biopsy and bacteriological examination confirm no unexpected foreign body reactions after removal of implant
Prenumeration
Beskrivning
| Land | Norge |
|---|---|
| Lista | OB Match |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Bergen, Norway, 08 October 2024: Today, Lifecare ASA (LIFE), a clinical stage medical sensor company developing the next generation Continuous Glucose Monitor (CGM), can confirm no unexpected tissue or body response based on bacteriological and biopsy tests after removal of the implanted sensor used in first longevity study. In addition, post study testing of the sensor in-vitro confirm intact glucose-sensitivity.
Reference is made to the press release from 11 September 2024 when the company announced the successful completion of the first veterinary patient in the longevity trial after 12 weeks. The sensor was removed in accordance with the regulatory approved protocol. Lifecare’s team has now completed a thorough analysis of both the surrounding tissue and the implant, after removal.
Prior to implanting the sensor in late June, the glucose sensitivity of the implant was tested and due to good results declared ready for the implantation. After 12 weeks of implantation the implant was removed from the dog.
Biopsies and bacteriological tests of tissue surrounding the sensor under Elli’s skin conducted at Norwegian University of Life Sciences (NMBU), shows no swelling and infection in the wound post-operatively and no adverse effects in the dog.
In-vitro functionality tests of the implant after removal have shown that the sensor is fully glucose sensitive. The scientific team has concluded that the implant was stable over the period of 12 weeks.
- We are especially pleased that the biopsies and bacteriological examinations confirm the visual inspections during the removal of the implant after 12 weeks, showing no unexpected foreign body reactions. The primary goal of the first sensor in the longevity trial was to investigate foreign body reactions and to confirm the sensors operational lifespan in a long-term perspective. These goals have been met in this first part of the study, says Holter.
- Retrieving the sensor from Elli has provided a valuable insight to further understand the sensor's characteristics and helped identify potential areas for improvement. We are also very pleased to report that biopsy tests show no signs of adverse effects in our first patient of our longevity trial, says Jo Amundstad at Lifecare Veterinary.
Lifecare plan to initiate the next phase of testing in the upcoming weeks, the initiation is subject to internal quality control of produced sensors and bacteriological tests prior to implantation.