The Operating Theatre Journal - Journal - Page 19
Isansys’ remote patient monitoring system integral
to ground-breaking health study in Germany
All participants received a tablet for vital data monitoring. Depending
on their prescription, participants took home a cardio patch, a pulse
oximeter, and/or a blood pressure monitor, all provided by Isansys
Lifecare Europe GmbH (Teltow, Germany; HQ in Oxford, UK) for the
duration of the test.
The devices, approved as medical devices, facilitate the automatic
transfer of vital data to the tablet, which is then transmitted to the
relevant GP practice via an app. This seamless data transfer enables
quick recognition of abnormalities, contributing to more effective
patient care.
Patients from the German town of Attendorn are being prescribed vital
data monitoring as part of a study into how telemedicine can support
healthcare to tackle the challenge of rural ambulatory care in the
future in the context of changing demographics and staff shortages.
Keith Errey, co-founder and CEO of Isansys, said: “We are excited to
be part of this ground-breaking project that showcases the potential
of remote patient monitoring in advancing healthcare for patients in
any setting. The Patient Status Engine is designed to provide real-time,
actionable insights, and its role in this study underscores its capability
to contribute to the future of healthcare delivery.”
The Telemed@ATN study is currently in its testing phase, with 20
patients engaging in remote vital data monitoring from the comfort of
their homes.
The research, approved by the ethics committee of Witten/Herdecke
University, is a crucial initiative in context of data medicine to assess
the impact of digital and telemedical approaches on healthcare in
Attendorn. The carefully selected participants, split equally between
two medical practices - Laufenberg & Schulze MD and Rustemeyer &
Falke MD - are prescribed vital data monitoring as part of the research
project.
The town of Attendorn is co-funding the study with the aim to help
reduce the workload of medical staff in local doctor’s of昀椀ces and
maintain high-quality healthcare services. The project lead and
scienti昀椀c supervision for evaluation is conducted by the Digitale
Modellregion Gesundheit Dreiländereck (DMGD), Siegen University.
Before the commencement of vital data monitoring, Prof Nabeel
Farhan, MD, conducted individual interviews with patients to ensure
a personalised approach to their healthcare needs. The primary
objective is not only to enhance general practitioner care but also to
evaluate the seamless transmission of data and patient comfort during
the monitoring period.
Participants will provide insights into the test process through
questionnaires, with feedback from the medical practices also
considered in the analysis.
Further updates on the progress and 昀椀ndings of the study will be
available soon. The current article can be found here:
https://dmgd.de/2023/12/06/attendorn-vitaldatenmonitoring/
The project’s website can be reached here:
https://dmgd.de/projekt/telemed-at-atn/
Biocomposites’ investee Renovos Biologics receives FDA Breakthrough Device
Designation for its synthetic nanoclay bone fusion gel, RENOVITE® BMP-2
• RENOVITE® BMP-2 is being developed as an alternative to bone graft materials for interbody spinal fusion
• It is the 昀椀rst product based on RENOVITE®, Renovos’ novel nanoclay therapeutic delivery platform for precision regenerative medicine
Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating bone
and managing infection in bone and soft tissue, is pleased to announce that its investee company, Renovos Biologics (Renovos), has been granted
Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its lead product, RENOVITE® BMP-2 (Bone Morphogenic Protein
2).
RENOVITE® BMP-2, based on a proprietary synthetic nanoclay gel, is in development as a safer and more effective alternative to currently
available bone graft materials. The easy-to-use, injectable gel allows precise, localised bone formation at the target site. It contains BMP-2, a
growth factor which promotes in-growth of bone forming cells. The nanoclay gel enables safe, highly-targeted bone fusion, as it does not leach
BMP-2, with the gel biodegrading as new bone forms.
Dr Agnieszka Janeczek, Chief Executive Of昀椀cer of Renovos Biologics, said: “We are very pleased with the Breakthrough Device Designation from
the FDA, being among just one hundred or so companies granted this designation in orthopaedics since the programme’s launch in 2015. This
designation is a major milestone in our development journey. The accelerated regulatory feedback and prioritised review will shorten the time to
market and allow faster access to expanded treatment options for patients suffering from degenerative disc disease.”
Michael Harris, Chief Executive Of昀椀cer of Biocomposites, said: “The granting of FDA Breakthrough Device Designation is a transformational
step for Renovos, supporting its goal to rapidly develop and bring to market RENOVITE® - a next-generation drug carrier. At Biocomposites, our
expertise in this 昀椀eld ideally positions us to support and enhance RENOVITE®’s progress towards pre-market approval.”
The FDA’s Breakthrough Device Designation program is intended to help provide patients more timely access to medical devices which have
the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions, by speeding up the
development, assessment and review process. Breakthrough designation is only granted after preliminary evidence has been provided demonstrating
a reasonable expectation that the device will provide signi昀椀cant advantages over standard of care. The designation will allow Renovos to have
more frequent interaction with the FDA’s regulatory experts when preparing its submissions, followed by prioritised reviews.
Please visit: https://biocomposites.com/ to learn more.
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Issue 400
January
2024
19