CDSCO Panel Flags Inadequate Data, Withholds Pilot Study Nod for BPH Pulse Field Ablation Device

At its 7th/25 meeting held on 21 August 2025 at CDSCO headquarters in New Delhi, the committee reviewed the proposal by M/s Trialguna Private Limited for conducting a clinical study of the BPH Pulse Field Ablation Device, manufactured by M/s ALPFA Medical, USA. According to the SEC minutes, “The said device is intended to be used for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH) in men above 45 years of age.” The committee also noted that, “The said device is not yet approved by any country. There is no clinical data generated on human subject. The proposed clinical study is a part of global study. The other countries involved in the said study are Italy and Czech Republic for generation of safety and feasibility of the medical device.” After detailed deliberation, the SEC listed multiple concerns: “The pre-clinical study data submitted by the firm was not adequate.” “The firm should submit the clinical study data generated on the human subjects globally to prove safety and effectiveness of the said device.” “Also, the said device is not yet approved by any of the National Regulatory Authorities, i.e. Country of Origin (USA) or other countries viz. EU, UK, etc. Therefore, the regulatory approval of the said medical device in the country of origin (USA) or other countries where the study is ongoing shall be submitted.” “OECD certification of the lab where the preclinical study is carried out, need to be submitted, before taking necessary action in the matter.” The committee concluded that regulatory approval and more robust global data are necessary prerequisites before the proposed trial can proceed in India.