# BioCardia Finishes Japan PMDA Consultation on CardiAMP, Targets 2028 Revenue

> BioCardia completed its PMDA consultation on CardiAMP application materials, moving toward a Japanese marketing approval filing and first patient treatments in 2028.

- Published: 2026-11-06T14:14:40+00:00
- Section: Regulation & Approvals
- Author: News Desk
- URL: https://newsforagent.com/news/2026-11-06/biocardia-pmda-consultation-cardiamp
- Source: [Stock Titan](https://www.stocktitan.net/news/BCDA/bio-cardia-completes-clinical-consultation-process-with-japan-s-pmda-j0hq80uwb2h5.html)

## Key takeaways

- BioCardia completed its consultation with Japan's PMDA on the application materials for the CardiAMP Cell Therapy System.
- BioCardia CEO Peter Altman said the company targets first patient treatments in Japan and commercial revenues in 2028.
- Completion of the consultation is not regulatory approval; CardiAMP remains subject to PMDA review.

[BioCardia](https://akta.pro/company-profiles/0000rwo/biocardia) has completed its consultation process with Japan's Pharmaceuticals and Medical Devices Agency on the application materials needed to obtain regulatory approval in Japan for its CardiAMP Cell Therapy System for ischemic heart failure. [Stock Titan](https://www.stocktitan.net/news/BCDA/bio-cardia-completes-clinical-consultation-process-with-japan-s-pmda-j0hq80uwb2h5.html) reported the announcement on November 6, 2026. The company targets first patient treatments in Japan and commercial revenues in 2028.

## What BioCardia's PMDA Consultation Covered

BioCardia, a clinical-stage biotechnology company developing autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases, said the completed consultation covers the materials required for a Japanese marketing approval application. CardiAMP is intended as a minimally invasive, catheter-based autologous cell therapy for patients with ischemic heart failure. The therapy has been evaluated in three clinical trials involving more than 200 patient procedures, including two randomized, double-blind, placebo-controlled trials.

"With the completion of consultations with PMDA regarding our application materials, we are closer to the day when we can provide CardiAMP cell therapy to heart failure patients in Japan," said Peter Altman, Ph.D., BioCardia's chief executive officer. "The extensive work completed with PMDA positions us to initiate the process toward final regulatory approval review."

BioCardia said completion of the consultation does not constitute regulatory approval and that CardiAMP remains subject to PMDA review and applicable Japanese regulatory requirements. [TradingView](https://www.tradingview.com/news/tradingview:67674c7956dda:0-biocardia-bcda-completes-pmda-consultation-targets-japan-revenue-in-2028/) also noted that approval remains pending. Japan's PMDA published review points for medical devices using generative AI in October 2026, addressing the absence of a framework for evaluation and risk management, Medical Buyer reported.

## BioCardia's Funding and FDA Records

According to akta.pro [company records](https://akta.pro/company-data), BioCardia raised $4.4 million in June 2026 through a public offering of 3,509,604 shares at approximately $1.279 per share with no warrants, extending its cash runway into the first quarter of 2027 and covering the planned Japan PMDA submission. The same records list total funding of $58.9 million, with the last round dated June 5, 2026, and a market capitalization of $10-12 million.

## BioCardia's Earlier Regulatory Steps

In October 2026, BioCardia said the FDA accepted its revised De Novo pre-submission for the Helix catheter, with substantive review and written feedback expected that quarter, TradingView reported. In September 2026, AInvest reported that the FDA's biologics center said the CardiAMP Heart Failure II trial may support a PMA submission for ischemic heart failure, with a Japan submission guided for late 2026. In August 2026, Stock Titan reported that the FDA finalized the minutes from BioCardia's Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System.

## BioCardia's Next Regulatory Steps

BioCardia said it is targeting the treatment of its first patients in Japan and the realization of commercial revenues in 2028, with PMDA review of the CardiAMP application still required.

## Companies in this story

- [BioCardia company profile](https://akta.pro/company-profiles/0000rwo/biocardia) · website: http://www.biocardia.com

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