Last Updated on May 12, 2022 by GlobeNewsWire
LONDON, Ontario, May 11, 2022 (GLOBE NEWSWIRE) — In a release issued on May 10, 2022, by BLES Biochemicals Inc., please note that the headline has been updated, “BLES(R)” has been corrected to say “BLEScathTM” in the fourth paragraph, the second sentence in the last paragraph has been changed, NIPPV has been added in the sixth paragraph, citation numbers updated, and a fourth citation has been added to the References section. The corrected release follows:
An Innovative Pulmonary Surfactant Delivery Solution for Neonates with NRDS
BLES Biochemicals Inc. is an established global player in providing innovative solutions for neonatal respiratory distress syndrome (NRDS).
We are excited to introduce a unique, single-use, intratracheal catheter with an integrated stylet, designed by clinical experts who understand the practice and importance of delivering exogenous pulmonary surfactant to neonates.
BLEScathTM is intended for the administration of bovine lipid extract surfactant suspension (BLES(R)) using the minimally invasive surfactant therapy (MIST) / less invasive surfactant administration (LISA) technique for rescue treatment of infants with NRDS2. Health Canada has authorized BLEScathTM for sale in Canada.
BLEScathTM is intended for neonates at >= 28 weeks and or >= 1000 grams who do not require intubation or mechanical ventilation and meet the criteria for surfactant administration (i.e., oxygenation requirement met)2.
NRDS is a challenge mitigated by integrated scientific solutions. With the combination of BLEScathTM for use with BLES(R), we are equipped to provide a broader range of products to address and lead innovation for surfactant delivery to neonates experiencing NRDS. These neonates are unable to inflate the alveolar sacs in their lungs, resulting in progressive and diffuse atelectasis (collapse of lungs) and possible loss of life. Surfactant is an important component of NRDS treatment.
The LISA/MIST technique uses a small diameter catheter inserted into the trachea to deliver exogenous pulmonary surfactant to a spontaneously breathing patient supported by continuous positive airway pressure (nCPAP) or non-invasive positive pressure ventilation (NIPPV) to avoid intubation. The use of Magill forceps is often required to guide a thin catheter through the vocal cords and may impair the visual procedural field and may contribute to mucosal trauma3. BLEScathTM addresses these challenges with the integrated stainless steel (SS) stylet2.
Need to Know
The use of BLEScathTM and BLES(R) should be restricted to a highly supervised clinical setting with immediate availability of experienced neonatologists and other clinicians experienced with the general care of premature infants. Transient episodes of bradycardia and decreased oxygen saturation may occur during dosing1,2.BLEScathTM and BLES(R) are contraindicated in infants with active pulmonary hemorrhage1,2.DO NOT use BLEScathTM to administer any surfactant other than BLES(R)2.BLEScathTM is intended for intratracheal use only; do not introduce the catheter into other body openings2.
About BLES Biochemicals Inc.
BLES Biochemicals Inc. is an established global player in providing innovative solutions for treating NRDS. With over 40 years of research and the development of BLES(R), the leading pulmonary surfactant in Canada4, and now BLEScathTM , we strive to provide interventions that expand the standard of care practices.
Our researchers aim to complement existing practices and enhance neonatal care to alleviate NRDS-related mortality and morbidity. Many premature infants with NRDS may not have survived without treatment with an exogenous pulmonary surfactant, such as BLES(R). We believe that everyone deserves access to this therapy, and we work hard to make that a reality around the world. The innovation of BLEScathTM results from a continued commitment to that mission. We want to live in a world where every neonate with NRDS has access to life-saving pulmonary surfactant and associated delivery devices. Until this vision is realized, we continue to serve the underserved.
1.BLES(R) Product Monograph, January 31, 2022.
2.BLEScathTM Instructions for Use (IFU) December 31, 2020.
3.Herting E, Hartel C, Gopel W. Less invasive surfactant administration. Current Opinion in Pediatrics. 2020;32(2):228-34.
4.Data obtained from IQVIA Solutions Canada Inc.
BLES Biochemicals Inc.
Product Marketing Manager
519-457-2537 Ext 815
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/02172a7e-7d47-4325-870a-e818993599a5