NanoEntek Receives Additional FDA Approval for Frozen HPC-A Specimen with Hematopoietic Stem Cell Counter
NanoEntek has received additional approval from the U.S. Food and Drug Administration (FDA) for the application of its hematopoietic stem cell counter (ADAM II-CD34) to frozen hematopoietic progenitor cell apheresis (HPC-A) products.
According to NanoEntek on July 22, the ADAM II-CD34 had already received FDA approval for peripheral blood and umbilical cord blood, and with this additional approval for frozen HPC-A, the device can now test all key specimens used in hematopoietic stem cell transplantation with a single instrument. As a result, the number of NanoEntek’s products approved by the FDA under the 510(k) in vitro diagnostic medical device process now totals 13, marking the highest number among domestic immunodiagnostic companies.
Frozen HPC-A is a specimen used in autologous hematopoietic stem cell transplantation for patients with hematologic cancers. The patient’s hematopoietic stem cells are collected and frozen in advance, and before being reinfused after intensive chemotherapy, the cell count and viability are checked. With this latest approval, the ADAM II-CD34 can now be applied to critical quality control steps in the autologous stem cell transplantation process.
NanoEntek has also strengthened its growth base with a virtuous revenue structure where continuous sales of consumables follow equipment sales. Last year, 77.8% of total sales came from consumables in the in vitro diagnostics (IVD) and life sciences (LS) segments, and as global equipment supply expands, high-margin consumable sales are also growing accordingly.
In particular, the high-end, high-throughput cell analysis instrument series “EVE-HT,” which is used by more than 30 global pharmaceutical and biotech companies, is expected to generate cumulative consumable revenue over about three years that matches the original equipment sales price. As major equipment supply expands, NanoEntek has established an accumulating business model where consumable sales closely follow equipment installations.
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A NanoEntek representative stated, “With FDA approval, the clinical application scope of the ADAM II-CD34 has expanded further, establishing it as a key quality control instrument in the autologous hematopoietic stem cell transplantation process for hematologic cancers. We will continue to broaden the presence of the ADAM series in North American and European blood cancer transplantation centers, as well as in the Middle East, where there is high demand for the treatment of hereditary blood diseases.”
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