Clinical feedback from hospitals in India
During November/December, Calmark's Head of Sales, Magdalena Tharaldsen, completed a three-week tour of India, where she first travelled with Swecare as part of a delegation and subsequently continued the journey together with the Company's distributor r2 Hemostasis Diagnostics India Private Ltd. Calmark's bilirubinometer was demonstrated for health authorities and in hospitals. The clinical feedback collected is presented below.
The delegation trip was arranged by Swecare in cooperation with the Swedish Ministry of Health and Social Affairs, the Swedish embassy in New Delhi, the Consulate General in Mumbai, and Business Sweden, covering three different cities: Mumbai, Jodhpur, and New Delhi. Calmark Neo-Bilirubin was presented to health authorities and hospitals ranging from large public hospitals to high-tech private hospitals.
After the official program, the tour of India continued together with representatives of r2 Diagnostics. In total, nine hospitals in the New Delhi area were visited, including Safdarjung Hospital and Medical College, Rainbow Children Hospital, Army Hospital (Research & Referral) in Delhi, and Post Graduate Institute of Child Health in Noida. In Agra, an evening event was held on December 10 together with influential pediatricians to discuss current jaundice diagnostics and present Calmark Neo.
In India, bilirubin measurement is currently performed by both blood tests and skin screening. The blood samples are often sent to laboratories but there are also domestic solutions for point-of-care testing. These require centrifugation to separate the plasma and the quality is perceived to be low.
Skin screening is also not considered to work well enough. As such, there is some skepticism about POC solutions. A success factor for Calmark is therefore to prove the performance of Calmark's POC system.
Neo-Bilirubin was positively received, especially in that it uses whole blood, as this means that the blood does not need to be passed through a centrifuge. That the instrument is portable and easy to use is seen as advantages, and a major plus is that no calibration is required. The decisive element for the Indian hospitals is the ability to deliver peak performance. Thus, a special presentation of the analytical performance was made through Teams. Analytical performance means that a POC instrument must be capable of matching the measuring capacity of the reference method, the so-called “golden standard”, and consistently achieve a precision of CV[1] less than 10 percent. The fact that Calmark Neo-Bilirubin is NEST360 qualified is something that really builds credibility in India.
Indian hospitals are yet to achieve a significant degree of digitalization, and requests for connectivity were rarely brought up during the meetings.
“I take pride in announcing that this collaboration of r2 Hemostasis Diagnostics and Calmark will bring together Entrepreneurship combined with Calmark’s love for technology and design and will make us the leader in POC diagnostics in newborns which measures the bilirubin level in whole blood for jaundice detection.” says Shivani Agarwal, Director’s Operations at r2 Hemostasis Diagnostics. “Innovation is in Calmark’s DNA and I can’t wait to see how the company will develop and offer all relevant tests for the first period of life. We are honoured to be a part of this impeccable initiative and look forward to work together with greater synergy.”
"In every aspect, this was an amazing journey," concludes Magdalena Tharaldsen, Calmark’s Director International Business Development. "Getting such broad feedback from end users was invaluable, both for us and our distributor. To have the opportunity to go on this kind of initial marketing journey together at an early stage is important; now we can create a customized plan for the roll-out based on the needs expressed by opinion leaders. This gives us a major boost now that registration is nearing completion!”
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.
[1] CV = Coefficient of variance (%): The standard deviation divided by the mean, multiplied by 100. For Neo-Bilirubin, the CV compared to the reference method at the Karolinska University Hospital laboratory in the range of 150-500 µmol/L (9-29 mg/dL) is as low as 5.2 percent.
For more information about Calmark Sweden AB, please contact:
Camilla Arneving, Acting CEO
Telefon: +46 (0)10 204 01 50
E-post: camilla.arneving@calmark.se
www.calmark.se
Calmark Sweden AB is a medical technology company that manufactures and markets a point-of-care (POC) analysis method with easier and faster diagnostics of medical conditions in newborns. The unique test platform consists of a portable instrument and test cassettes for various biomarkers. The first test, Neo-Bilirubin, is CE marked and measures the bilirubin level in whole blood for jaundice detection in newborns. In the Western world, the introduction of POC diagnostics is resulting in huge savings and shorter care chains. In less developed healthcare systems, the product offers a decision support which is currently lacking, since the access to hospital laboratories often is limited. Calmark aims to become the global leader in POC diagnostics for newborns and, in the long term, to offer all relevant tests for the first period of life. The B share is listed on the Spotlight Stock Market and is traded under the CALMA B ticker. Read more at www.calmark.se/eng/home.
