バイオカルディア【BCDA】の掲示板

全員 “上昇イベント待ち” の珍しい構造🍵

●機関データ（12/6 fintel）
28社（longのみ）→ 需給の悪材料なし
前四半期比： 16.67%（Q3増）
● 株主構成
機関・insider等64.86%
個人20.28%→ 大口の判断が株価方向を決める
非公開会社11.55%
投資信託 2.06%
ヘッジファンド 1.22%
株式会社 0.04%

Integrated Timeline
（November 12, 2025 PR)

● Q4 2025
• CardiAMP HF Japan: PMDA Clinical Review begins
• CardiAMP HF: FDA meeting request on approvability submitted
• Helix Biotherapeutic Delivery System: De Novo 510(k) submission to FDA

● Q1 2026
• CardiAMP HF (Heart Failure): Publication of the CardiAMP HF manuscript
• CardiAMP CMI (Chronic Myocardial Ischemia): Publication of roll-in cohort data
• CardiALLO MSC Therapy (Heart Failure): Nondilutive funding milestone

● Ongoing (2025–2026)
• CardiAMP HF II enrollment continues (Phase 3b)

いずれCAPR並みの爆発力になる。
それまで放置🍵

直近マイルストーン（最大の注目点）

• 日本 PMDA クリニカルレビュー（Q4 2025）
→ 2025年Q4の PMDA 2回目ミーティング。
ここで「承認申請可能」とのガイダンスが出るかどうか。これが最大の分岐点。もし PMDA が「申請可能」と判断すれば、2026年〜2027年に日本承認の道筋が現実化🍵
• FDA approvability meeting（Q4 2025）
• Helix 510(k) 提出（Q4 2025）
• CardiAMP HF 論文公開（Q1 2026）
• CardiAMP 狭心症データの論文化（Q1 2026）
• CardiALLO 非希薄化資金の獲得（Q1 2026）

BioCardia – Q3 2025 Summary

BioCardia’s Q3 2025 update highlights progress in its cell therapy programs and delivery technologies, supported by a recent $6M financing.

●BCDA-01 CardiAMP (Autologous; HFrEF)
Three completed trials show consistent safety and benefit, with strongest effects in patients with elevated cardiac stress biomarkers. Two randomized double-blind trials met statistical significance on the composite endpoint now used in the ongoing Phase 3 CardiAMP HF II study. A positive preliminary PMDA meeting in Japan may lead to a market-entry submission. BioCardia plans to request an FDA approvability meeting in Q4 2025.

●BCDA-02 CardiAMP (Refractory Angina)
Roll-in cohort data show clear improvement: 80 seconds exercise tolerance, 82% reduction in angina episodes, and no treatment-emergent MACE, suggesting additive benefit on top of GDMT.

●BCDA-03 CardiALLO (Allogeneic MSCs)
The low-dose 20M-cell cohort showed no adverse events, arrhythmias, rejection, or allergic responses. DSMB approved continuation. This is the first study focused on ischemic HF with active inflammation.

●Delivery Platforms
The Helix catheter supports all programs and is planned for DeNovo 510(k) submission in Q4 2025. Heart3D imaging enables rapid, precise intramyocardial injections.

●Financials
R&D was $0.936M; SG&A $0.6M; net loss improved to $1.5M. Cash balance of $5.3M provides runway into Q2 2026.

●Milestones
PMDA review and FDA meeting request (Q4 2025); CardiAMP HF manuscript and angina cohort publication (Q1 2026); CardiALLO funding target (Q1 2026); Helix 510(k) submission (Q4 2025).

循環器の名門University of Wisconsinで初登録。
以下の記事要約では、Phase3とあるが、正しくはPhase3b。他医療機関でも進行中の商業化申請に向けた250人の最終治験。

BCDA announced that the University of Wisconsin enrolled its first patient in the Phase 3 CardiAMP HF II trial, which tests the safety and efficacy of CardiAMP autologous cell therapy for ischemic heart failure. The 250-patient study uses a composite primary endpoint and improved cell and delivery methods, with this enrollment expected to enhance the trial’s strength and reach.

問題なく前へ🍵

BioCardia (BCDA) has regained compliance with Nasdaq Capital Market listing standards. On October 1, 2025, Nasdaq confirmed the company meets Listing Rule 5550(b)(1), allowing BCDA to remain listed. This follows BioCardia’s efforts to strengthen its financial position and secure funding to support its therapeutic development and approved products.

あっという間に株価を戻してきましたね。
1990年代に創設してから心臓細胞医療のみに
特化してきたエビデンスの蓄積と実績は充分🍵

日本PMDA要請内容は、BCDAが余裕で対応できる内容のみ。年内の正式相談は確実視🍵

PMDAからの要請内容と難易度
・複合評価項目の位置づけ
　→ 解析計画に基づき整理するだけ
・統計学的パワーの根拠
　→ 試験デザイン時に既に算出済み
・NT-proBNPサブグループの臨床的意味づけ
　→ 米国データで説明可能
・日本での想定患者数
　→ 疫学データより推定するだけ
・米国での開発状況
　→ FDAとのやり取りを整理して提示

◾️BioCardia Summary (Sept 22, 2025)

• BioCardia held a positive preliminary clinical consultation with Japan’s PMDA regarding CardiAMP Heart Failure trial results.
• Purpose: preparation for a formal consultation on data acceptability for a potential approval application.
• PMDA requested clarifications on:
• Positioning of composite endpoints
• Statistical power rationale
• Clinical rationale for NT-proBNP subgroup and risk-benefit profile
• Target patient numbers in Japan
• U.S. clinical development status
• BioCardia is finalizing responses and expects a formal consultation by year-end.
• CEO Peter Altman emphasized commitment to patients with few treatment options, highlighting three completed trials in 178 ischemic HF patients and significant benefits seen in the CardiAMP HF study.

来年の日本申請に向けて、心不全以外にも
CardiAMP慢性心筋虚血（Chronic Myocardial Ischemia）のPhase 2試験（6か月データの速報）が完了した際には適応拡大するでしょうね
🍵

良い治験結果に併せて1.25ドルのワラント
今は仕方ないですね🍵

BioCardia (BCDA) Offering Summary
• Issuing 4.8M common shares plus 4.8M short-term warrants (exercise price: $1.25, expiring in 2 years).
• Offering price: $1.25 per share warrant.
• Gross proceeds: ~$6M upfront; potential additional ~$6M if all warrants exercised.
• Placement agent: H.C. Wainwright & Co.
• Closing: Expected around Sept 19, 2025.
• Use of proceeds: Working capital, corporate purposes, advancing biotherapeutics and delivery platform business.

Phase3bと同時に実施しているCardiAMP慢性心筋虚血（Chronic Myocardial Ischemia）のPhase 2試験（6か月データの速報）は良好🍵

最新結果（2025年9月18日発表）
・治療は良好に忍容
・運動耐容能が有意に改善
・狭心症発作が減少
・意義：標準治療で効果が得られない治療抵抗性狭心症に新しい選択肢を提供できる可能性

Summary
On September 18, 2025, BioCardia (NASDAQ: BCDA) announced top-line data from the roll-in cohort of the CardiAMP Chronic Myocardial Ischemia Trial. At the six-month primary follow-up, CardiAMP Cell Therapy was:

・Well tolerated by patients.
・Associated with significant improvements in exercise tolerance.
・Led to a reduction in angina episodes.

These results highlight the potential of CardiAMP Cell Therapy to address unmet medical needs in patients with chronic myocardial ischemia and refractory angina, strengthening BioCardia’s position in the cardiovascular therapeutics market.

BioCardia files to sell 2.8M shares of common stock, warrants

下落は仕方ないですね。資金が必要な時🍵
・日本での承認申請と商業化
・米国でのフル承認に必要なPhase3b

期待どおり2ドル台に戻してきました。
年末までにPMDA回答、来年に日本承認申請
でしょう🍵

2年前の重要なニュースを見落としていた。
日本PMDAは国内追加試験は不要と示唆済み。

BioCardia のCardiAMP-HF試験は、クオリプスと同じ NYHA クラス II–III の虚血性心筋症による慢性心不全を対象とし、しかも大規模シャム対照試験で長期的有効性を検証した実績があります。

クオリプスの心筋シートが Phase 2b 申請中に希少疾病用製品として指定された事例を踏まえれば、BioCardiaのカテーテル細胞療法に関する医療機器も、少なくとも、優先審査指定等の規制上の支援措置を適用するのが公平です。さもなくば、国内外から「日本の規制当局は整合性に欠ける」「外資系に不利だ」との評価を受けかねません。
2025年第4QPMDAとの協議結果に注視です🍵

Clinical Package
・PMDA does not require additional studies in Japan.
• Approval may be based on foreign clinical data, particularly from the CardiAMP Heart Failure Trial.

◾️BioCardia Update on PMDA Consultation for CardiAMP Cell Therapy (Nov 30, 2023)

• Context: BioCardia met with Japan’s PMDA regarding regulatory approval of its CardiAMP autologous cell therapy for ischemic heart failure with reduced ejection fraction (HFrEF).
• Preclinical Package: PMDA requested additional details; BioCardia believes these are easily addressable.

●Clinical Package:
・PMDA does not require additional studies in Japan.
・Approval may be based on foreign clinical data, particularly from the CardiAMP Heart Failure Trial.
• PMDA wants to review interim and final trial results.

●Indication Scope:
Initial approval may be limited to patients with NT-proBNP > 500 pg/ml, consistent with FDA-approved criteria for CardiAMP Heart Failure II.
• Next Steps:
・Formal meeting minutes expected in four weeks.
• Follow-up consultation planned.

●CEO Statement:
Peter Altman, PhD, emphasized the therapy’s minimally invasive nature and its potential to offer a safer alternative to open-heart cell therapies currently used in Japan.

CART-Tech B.V.の最新技術CARTBox はCE認証取得済み。これは同社技術がEU医療機器規制に適合し、欧州市場での使用が認められていることを示している信頼性と国際展開力の証。

Biocardiaを含むカテーテル細胞医療を開発する
企業と世界の医療現場が欲しがるだろう🍵

At CART-Tech, we are at the forefront of the cardiac intervention revolution, dedicated to enhancing cardiac care with our advanced image guidance technology. Our innovative CARTBox combines cloud computing and deep learning with sophisticated visualization hardware for precise cardiac device placement. With a strong intellectual property portfolio and a CE-certified platform, we lead in image-guided therapy, improving response rates and patient outcomes. We aim to transform cardiac care by offering precise, effective interventions that improve life quality and expectancy. Our services include real-time intervention guidance, advanced analysis, and continuous support to ensure effective integration of our technologies into clinical practice.

オランダCART-Techとの大型契約発表あり🍵
ここの基盤技術Heart3D Fusion Imagingを使うと、MRIやCTで事前に作った患者の3D心臓モデルを手術中のX線映像にリアルタイムで重ね合わせできる心臓カテーテル治療用GPS。

最大のメリットは、特定メーカーの医療装置に縛られず、今ある設備に“後から追加”して使える柔軟性。

Heart3Dは現状では動物試験などの研究用ツールですが、最短でも3年、現実的には4〜5年のプロセスを経て、細胞治療の臨床試験や商業利用に組み込める可能性が高い。

Date: August 13, 2025
Companies: BioCardia, Inc. (Nasdaq: BCDA)& CART-Tech B.V.
Subject: Exclusive Partnership– Heart3D™ Fusion Imaging

BioCardia and CART-Tech have formed an exclusive partnership to develop and commercialize Heart3D™ Fusion Imaging, a system that merges 3D heart models from MRI/CT with real-time 2D X-ray images to guide cardiac biotherapeutic delivery and biopsy procedures. Initially, it will be sold as a research tool for preclinical studies, with plans for later regulatory approval for clinical use. BioCardia gains exclusive worldwide rights for biotherapeutic delivery and U.S. rights for cardiac biopsy, while CART-Tech retains other rights. The technology aims to improve procedural planning, image precision, and patient outcomes, with a potential $100M annual revenue opportunity if adopted as a standard of care. Currently, the system is for investigational use only and not yet CE-marked or FDA approved.

株価低迷理由は明白で心配無用。日本商業化を強調する理由も、米国Phase3b完了までの資金調達の一環と考えれば分かりやすい🍵。

Cash balance on June 30, 2025, was approximately $980,000. During the period from July 1, 2025 to August 8, 2025, we sold an aggregate of 296,422 shares of common stock under our ATM program at an average price of $2.59 per share to total gross proceeds of $769,000. This brings our current cash balance to approximately $1.1 million and provides runway into October 2025.

1.8ドル未満で静かに全力買いです。
第4Qには日本上陸に関する話題もニュースに
なるでしょう🍵

アメリカと日本で事情が異なるので補足🍵

❶日本での承認対象
BCDAが日本で承認を取りたいのは 「細胞」ではなく「医療機器」

該当するのは以下3種類
①Helix Transendocardial Delivery System（心筋内注入用カテーテル）
②CardiAMP（自家骨髄単核球を現場処理して心筋投与するプラットフォーム、医療機器扱い）
③BioCUE Cell Processing System（細胞処理装置、Zimmer Biometがすでに整形外科用途で承認済み）

❷日本の早期承認制度との関係
日本の「再生医療等製品」の早期承認制度は、有効性推定ができる程度のエビデンス（Phase 2相当）があれば申請可能
●CardiAMPの場合
①米国ではPhase 3b（HFII確認試験）進行中
②Phase 1（TABMMI）、Phase 2（TAC-HFT）、Phase3（HFI試験・二重盲検・115例）などエビデンスを保有。
→早期承認制度で求められるPhase 2レベルの
データは十分満たしている。

◾️不確定要素
Q4 2025のPMDA対面相談で最も注視するポイントは追加治験の必要性

術者習熟度や安全管理がカギになる医療機器では、日本での限定的治験（10〜20例程度）を承認条件にすることがある。使用経験確認試験の位置づけ。

Helix Transendocardial Delivery System（通称Helix system）を医療機器としてFDA申請を第3Qに行うアナウンスあり。
Helix systemサポート機器Morph® Universal Deflectable GuideはFDA承認済みであり、投与する医療機器は、完成の域に達したと言える。あとは細胞開発のみ。
記事の最後に日本開発に関しても触れられている。今後の動向に注目していきたい🍵

◾️HP要約
BioCardia Regulatory Update – August 4, 2025

BioCardia announced the following regulatory milestones for its CardiAMP® Cell Therapy System and Helix™ Transendocardial Delivery Catheter:

◾️United States – FDA
●Q3 2025:
BioCardia plans to submit a De Novo 510(k) application to the FDA for Helix, based on safety and performance data from 12 cell/gene therapy trials and over 4,000 intramyocardial injections, including CE-marked use in Europe. Helix demonstrated superior therapeutic agent retention compared to other delivery methods.
●Q4 2025:
BioCardia will request a meeting with the FDA to discuss the approval pathway for CardiAMP Cell Therapy for ischemic heart failure, supported by:
・Prior Breakthrough Device Designation by the FDA.
・Clinical data from 63 patients across Phase I (TABMMI), Phase II (TAC-HFT), and CardiAMP HF roll-in trials.
・Two-year follow-up results from the 115-patient randomized, double-blind, placebo-controlled CardiAMP HF trial.
・Existing FDA 510(k) clearance of the MarrowStim cell processing platform (used in CardiAMP) for other indications.
・Ongoing CardiAMP HF II confirmatory trial at major U.S. sites.
◾️Japan – PMDA
●Q4 2025
BioCardia expects an in-person clinical consultation with PMDA regarding CardiAMP Cell Therapy. If aligned, this could lead to a regulatory submission for Japan market entry.
・PMDA has advised that if CardiAMP is approved, Helix could be referenced by other biologic developers, potentially expanding its regulatory reach.
・CardiAMP is regulated as a medical device in Japan, unlike allogeneic cell therapies requiring immunosuppression and surgical delivery.
・The BioCUE cell processing system, equivalent to CardiAMP’s platform, is already approved in Japan for orthopedic use by Zimmer Biomet.