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Butterfly Medical

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uuid0002duh

Namestring
Butterfly Medical
Legal namestring
Butterfly Medical Ltd.
Company typeenum
Private
Founded yearint
2014
Descriptiontext

Butterfly Medical Ltd. is a privately held, venture-backed Israeli medical device company developing the Butterfly Prostatic Retraction Device, a minimally invasive implant for the treatment of benign prostatic hyperplasia (BPH). The device works by physically retracting the lateral lobes of the prostate to relieve urinary obstruction without cutting, burning, or puncturing tissue, distinguishing it from TURP, laser, Rezum, Urolift, and other ablative BPH procedures. It is designed as a long-term yet reversible implant that allows future urological intervention if needed, and the procedure can be performed under local anesthesia across hospital, ambulatory surgery center (ASC), and office-based urology clinic settings, supported by a simple learning curve for community urologists. The company is headquartered in Yokneam, Israel, with a small 1–10-person team and senior leadership drawn from Olympus, Coloplast, Abbott Vascular, and the Israeli medtech entrepreneurial ecosystem.

The Butterfly device is CE Mark approved and commercially available in the European Union and remains investigational in the United States, where the company is preparing a Pre-Market Approval (PMA) application supported by a completed 244-patient international pivotal trial whose 12-month follow-up was finalized in January 2026. Butterfly Medical's business model is hardware sales — a one-time sale of the implantable device to hospitals, ASCs, and urology clinics, with pricing that is not publicly disclosed and expected to be quote-based / contract-negotiated at the time of commercial launch. The planned U.S. go-to-market is a direct enterprise field-sales motion, anchored by CEO Patrick MacCarthy's prior U.S. BPH treatment launch at Olympus, and supported by board member Steffen Hovard's prior role as President of Interventional Urology at Coloplast. As of May 2026, the company had raised approximately $30 million in equity across multiple funding rounds, most recently a $21 million oversubscribed Series C led by participation from the European Innovation Council, Junson Capital, MedVenture, and New Rhein Healthcare Investors, alongside a non-dilutive €2.5 million EIC grant.

Short descriptiontext

Butterfly Medical Ltd. is an Israeli medical device company developing the Butterfly Prostatic Retraction Device, a minimally invasive, reversible, tissue-sparing implant for benign prostatic hyperplasia (BPH). CE Mark approved in Europe and pursuing FDA PMA in the U.S.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
1–10
akta.pro rankint
HeadquartersYoqne`am `illit, Israel
HQ citystring
Yoqne`am `illit
HQ countrystring
Israel
HQ regionstring
Middle East
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
minimally invasive urology, benign prostatic hyperplasia treatment, implantable medical devices, prostatic retraction device, BPH surgical alternatives
Product category
Urology Medical Devices (BPH Treatment)
GTM motion3 records

Each record includes

Type, Description, Source

Revenue model1 record
1Sale of implantable prostatic retraction device
TypeHardware Sales
Description

Primary revenue stream is one-time sale of the Butterfly Prostatic Retraction Device to hospitals, ambulatory surgery centers (ASCs), and urology clinics. The device is CE Mark approved in Europe (commercially available) and investigational in the U.S. (limited by federal law to investigational use) pending FDA Pre-Market Approval, meaning U.S. revenue is contingent on regulatory clearance and a future commercial launch.

butterfly-medical.com
Marketing channels5 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels2 records

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components6 values
Technology or R&D, Supply Chain, Operations, Marketing or Sales, Personnel, Infrastructure
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 record
1Butterfly Prostatic Retraction Device
Description

The company's flagship CE-marked implantable device for minimally invasive treatment of benign prostatic hyperplasia (BPH).

butterfly-medical.com
Core offering1 text field

Butterfly Medical develops the Butterfly Prostatic Retraction Device, an implantable medical device that treats benign prostatic hyperplasia (BPH) by physically retracting the lateral lobes of the prostate without cutting, burning, or puncturing tissue. The device is fully reversible, designed as a long-term implant that still permits future urological intervention, and can be deployed under local anesthesia across clinic, ASC, and hospital settings. The product is CE Mark approved for commercial sale in Europe and investigational in the United States pending FDA Pre-Market Approval.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 4 values shown
  • 244 patients completed the international pivotal trial with 12-month follow-up completed in January 2026, supporting the planned FDA PMA submission.
+3 more records
Product overview1 text field

Butterfly Medical's offering is a single, unified core product — the Butterfly Prostatic Retraction Device — rather than a platform-plus-modules architecture. It is a new-generation, minimally invasive implantable medical device for Benign Prostatic Hyperplasia (BPH) treatment that retracts prostatic lateral lobes without cutting, burning, or puncturing tissue. The device holds CE Mark approval in Europe, is investigational in the U.S. pending FDA Pre-Market Approval (PMA), and is supported by a 244-patient international pivotal clinical study whose 12-month follow-up was completed in January 2026 to support the planned PMA filing.

Product and service1 record
1Butterfly Prostatic Retraction Device
CategoryImplantable Medical Device (Urology / BPH Treatment)
Description

An innovative, minimally invasive implantable device for the treatment of Benign Prostatic Hyperplasia (BPH) that retracts the lateral lobes of the prostate without cutting, burning, or puncturing tissue. Designed to be long-term yet reversible and allow future intervention if needed. The procedure is non-surgical, simple to learn, can be performed under local anesthesia, and is applicable across clinic, ambulatory surgery center (ASC), and hospital settings. Sold to hospitals, ASCs, and office-based urology clinics. Holds CE Mark in Europe and is investigational in the U.S. pending FDA PMA.

Scale indicator7 records

Each record includes

Type, Value, Description, Source

Recent move5 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeEmerging player
Description

ProVerum is developing a minimally invasive implant-based BPH therapy that mechanically reshapes the prostatic urethra. Its mechanism, target patient population, and care-setting strategy closely parallel Butterfly's, making it a relevant emerging peer.

TypeEmerging player
Description

Zenflow is developing the Spring System, a minimally invasive nitinol implant for BPH designed to be delivered in an office setting under local anesthesia. Its office-based, low-anesthesia positioning closely mirrors Butterfly's clinic/ASC value proposition.

TypeDirect peer
Description

Medifocus has historically commercialized the Prolieve thermodilatation system, a minimally invasive office-based BPH treatment. It is a smaller-scale but directly comparable office-based BPH modality and a relevant prior-art reference for Butterfly's outpatient positioning.

TypeDirect peer
Description

PROCEPT BioRobotics markets Aquablation/Hydros, an FDA-cleared robotic waterjet ablation system for BPH. It competes head-to-head with Butterfly in the minimally invasive surgical BPH space, particularly in larger prostates and hospital/ASC settings.

TypeEmerging player
Description

SRS Medical has developed urological device platforms including BPH-related technologies. It is an adjacent emerging player in the office-based urology device space where Butterfly is positioning its simple, local-anesthesia procedure.

TypeDirect peer
Description

Laborie (via Urotronic) is developing the Optilume BPH system, a drug-coated balloon dilation technology for BPH. It is a direct emerging competitor in the minimally invasive BPH category targeting the same urologist base.

TypeBroad incumbent
Description

Coloplast is a global urology and continence care incumbent whose Interventional Urology business is the largest commercial urology platform relevant to Butterfly. Board member Steffen Hovard was previously President of this division, and Coloplast's urology sales force defines the channel Butterfly will ultimately need to access or partner around.

TypeBroad incumbent
Description

Boston Scientific acquired NxThera and markets Rezum, a minimally invasive water-vapor thermal therapy for BPH. Rezum is one of the established non-surgical BPH alternatives against which Butterfly will compete for urologist adoption and reimbursement.

TypeBroad incumbent
Description

Olympus acquired iTind, a temporarily implanted nitinol device for BPH that is later removed. iTind is a directly comparable temporary-implant BPH modality, and Olympus is also Butterfly CEO Patrick MacCarthy's former employer, making it both a competitor and a relevant reference point for Butterfly's commercial playbook.

TypeDirect peer
Description

Teleflex acquired NeoTract and markets the Urolift System, the leading FDA-approved minimally invasive implant for BPH that lifts and holds enlarged prostate tissue. Urolift is the closest direct mechanistic and clinical competitor to Butterfly's lateral-lobe retraction implant, competing for the same urology channel and the same patient population.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks5 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment4 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile3 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature5 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles7 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
Compliance2 records

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds6 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors7 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Butterfly Medical

Urology Medical Devices (BPH Treatment)butterfly-medical.com

Butterfly Medical Ltd. is an Israeli medical device company developing the Butterfly Prostatic Retraction Device, a minimally invasive, reversible, tissue-sparing implant for benign prostatic hyperplasia (BPH). CE Mark approved in Europe and pursuing FDA PMA in the U.S.

What Butterfly Medical does

Butterfly Medical Ltd. is a privately held, venture-backed Israeli medical device company developing the Butterfly Prostatic Retraction Device, a minimally invasive implant for the treatment of benign prostatic hyperplasia (BPH). The device works by physically retracting the lateral lobes of the prostate to relieve urinary obstruction without cutting, burning, or puncturing tissue, distinguishing it from TURP, laser, Rezum, Urolift, and other ablative BPH procedures. It is designed as a long-term yet reversible implant that allows future urological intervention if needed, and the procedure can be performed under local anesthesia across hospital, ambulatory surgery center (ASC), and office-based urology clinic settings, supported by a simple learning curve for community urologists. The company is headquartered in Yokneam, Israel, with a small 1–10-person team and senior leadership drawn from Olympus, Coloplast, Abbott Vascular, and the Israeli medtech entrepreneurial ecosystem.

The Butterfly device is CE Mark approved and commercially available in the European Union and remains investigational in the United States, where the company is preparing a Pre-Market Approval (PMA) application supported by a completed 244-patient international pivotal trial whose 12-month follow-up was finalized in January 2026. Butterfly Medical's business model is hardware sales — a one-time sale of the implantable device to hospitals, ASCs, and urology clinics, with pricing that is not publicly disclosed and expected to be quote-based / contract-negotiated at the time of commercial launch. The planned U.S. go-to-market is a direct enterprise field-sales motion, anchored by CEO Patrick MacCarthy's prior U.S. BPH treatment launch at Olympus, and supported by board member Steffen Hovard's prior role as President of Interventional Urology at Coloplast. As of May 2026, the company had raised approximately $30 million in equity across multiple funding rounds, most recently a $21 million oversubscribed Series C led by participation from the European Innovation Council, Junson Capital, MedVenture, and New Rhein Healthcare Investors, alongside a non-dilutive €2.5 million EIC grant.

Butterfly Medical firmographics

Firmographics
Name
Butterfly Medical
Legal name
Butterfly Medical Ltd.
Website
http://www.butterfly-medical.com
Company type
Private
Founded year
2014
Operating status
Operating
Headcount range
1–10 employees
Short description
Butterfly Medical Ltd. is an Israeli medical device company developing the Butterfly Prostatic Retraction Device, a minimally invasive, reversible, tissue-sparing implant for benign prostatic hyperplasia (BPH). CE Mark approved in Europe and pursuing FDA PMA in the U.S.
Ownership category
akta.pro rank

Where Butterfly Medical is headquartered

Location

Headquarters

HQ city
Yoqne`am `illit
HQ country
Israel
HQ region
Middle East

Offices1 record

Markets served

Butterfly Medical business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Supply Chain, Operations, Marketing or Sales, Personnel, Infrastructure

Revenue model

  1. Sale of implantable prostatic retraction device: Primary revenue stream is one-time sale of the Butterfly Prostatic Retraction Device to hospitals, ambulatory surgery centers (ASCs), and urology clinics. The device is CE Mark approved in Europe (commercially available) and investigational in the U.S. (limited by federal law to investigational use) pending FDA Pre-Market Approval, meaning U.S. revenue is contingent on regulatory clearance and a future commercial launch.

Go-to-market motion3 records

Distribution channels2 records

Marketing channels5 records

Butterfly Medical product offering

Product offering

Core offering

Butterfly Medical develops the Butterfly Prostatic Retraction Device, an implantable medical device that treats benign prostatic hyperplasia (BPH) by physically retracting the lateral lobes of the prostate without cutting, burning, or puncturing tissue. The device is fully reversible, designed as a long-term implant that still permits future urological intervention, and can be deployed under local anesthesia across clinic, ASC, and hospital settings. The product is CE Mark approved for commercial sale in Europe and investigational in the United States pending FDA Pre-Market Approval.

Product overview

Butterfly Medical's offering is a single, unified core product — the Butterfly Prostatic Retraction Device — rather than a platform-plus-modules architecture. It is a new-generation, minimally invasive implantable medical device for Benign Prostatic Hyperplasia (BPH) treatment that retracts prostatic lateral lobes without cutting, burning, or puncturing tissue. The device holds CE Mark approval in Europe, is investigational in the U.S. pending FDA Pre-Market Approval (PMA), and is supported by a 244-patient international pivotal clinical study whose 12-month follow-up was completed in January 2026 to support the planned PMA filing.

Differentiator

Problem solved

Functional benefit

Brands

  • Butterfly Prostatic Retraction Device: The company's flagship CE-marked implantable device for minimally invasive treatment of benign prostatic hyperplasia (BPH).

Products and services

  • Butterfly Prostatic Retraction Device An innovative, minimally invasive implantable device for the treatment of Benign Prostatic Hyperplasia (BPH) that retracts the lateral lobes of the prostate without cutting, burning, or puncturing tissue. Designed to be long-term yet reversible and allow future intervention if needed. The procedure is non-surgical, simple to learn, can be performed under local anesthesia, and is applicable across clinic, ambulatory surgery center (ASC), and hospital settings. Sold to hospitals, ASCs, and office-based urology clinics. Holds CE Mark in Europe and is investigational in the U.S. pending FDA PMA.

Quantifiable outcome

  • 244 patients completed the international pivotal trial with 12-month follow-up completed in January 2026, supporting the planned FDA PMA submission.
  • +3 more outcomes

Companies that use Butterfly Medical

Customer profile

Segments4 records

Ideal customer profiles3 records

Butterfly Medical technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature5 records

Butterfly Medical partnerships and signals

Strategic signal

Scale indicators7 records

Recent moves5 records

Expansion highlights5 records

Butterfly Medical competitors and assessment

Company assessment

Emerging players

  • ProVerum: ProVerum is developing a minimally invasive implant-based BPH therapy that mechanically reshapes the prostatic urethra. Its mechanism, target patient population, and care-setting strategy closely parallel Butterfly's, making it a relevant emerging peer.
  • Zenflow: Zenflow is developing the Spring System, a minimally invasive nitinol implant for BPH designed to be delivered in an office setting under local anesthesia. Its office-based, low-anesthesia positioning closely mirrors Butterfly's clinic/ASC value proposition.
  • SRS Medical: SRS Medical has developed urological device platforms including BPH-related technologies. It is an adjacent emerging player in the office-based urology device space where Butterfly is positioning its simple, local-anesthesia procedure.

Direct peers

  • Medifocus: Medifocus has historically commercialized the Prolieve thermodilatation system, a minimally invasive office-based BPH treatment. It is a smaller-scale but directly comparable office-based BPH modality and a relevant prior-art reference for Butterfly's outpatient positioning.
  • PROCEPT BioRobotics: PROCEPT BioRobotics markets Aquablation/Hydros, an FDA-cleared robotic waterjet ablation system for BPH. It competes head-to-head with Butterfly in the minimally invasive surgical BPH space, particularly in larger prostates and hospital/ASC settings.
  • Laborie / Urotronic (Optilume BPH): Laborie (via Urotronic) is developing the Optilume BPH system, a drug-coated balloon dilation technology for BPH. It is a direct emerging competitor in the minimally invasive BPH category targeting the same urologist base.
  • Teleflex (NeoTract / Urolift): Teleflex acquired NeoTract and markets the Urolift System, the leading FDA-approved minimally invasive implant for BPH that lifts and holds enlarged prostate tissue. Urolift is the closest direct mechanistic and clinical competitor to Butterfly's lateral-lobe retraction implant, competing for the same urology channel and the same patient population.

Broad incumbents

  • Coloplast: Coloplast is a global urology and continence care incumbent whose Interventional Urology business is the largest commercial urology platform relevant to Butterfly. Board member Steffen Hovard was previously President of this division, and Coloplast's urology sales force defines the channel Butterfly will ultimately need to access or partner around.
  • Boston Scientific (Rezum / NxThera): Boston Scientific acquired NxThera and markets Rezum, a minimally invasive water-vapor thermal therapy for BPH. Rezum is one of the established non-surgical BPH alternatives against which Butterfly will compete for urologist adoption and reimbursement.
  • Olympus (iTind): Olympus acquired iTind, a temporarily implanted nitinol device for BPH that is later removed. iTind is a directly comparable temporary-implant BPH modality, and Olympus is also Butterfly CEO Patrick MacCarthy's former employer, making it both a competitor and a relevant reference point for Butterfly's commercial playbook.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

Butterfly Medical social profiles

Digital presence

Butterfly Medical compliance and trust

Trust signal

Compliance2 records

Butterfly Medical financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Butterfly Medical leadership team

Management profile

Number of profiles

Profiles7 records

Butterfly Medical funding detail

Funding detail

Funding overview

Funding rounds6 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Butterfly Medical M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Butterfly Medical

What does Butterfly Medical do?

Butterfly Medical develops the Butterfly Prostatic Retraction Device, an implantable medical device that treats benign prostatic hyperplasia (BPH) by physically retracting the lateral lobes of the prostate without cutting, burning, or puncturing tissue. The device is fully reversible, designed as a long-term implant that still permits future urological intervention, and can be deployed under local anesthesia across clinic, ASC, and hospital settings. The product is CE Mark approved for commercial sale in Europe and investigational in the United States pending FDA Pre-Market Approval.

Is Butterfly Medical a public or private company?

Butterfly Medical is a private company. It is classified as venture growth investor backed and is currently operating.

When was Butterfly Medical founded?

Butterfly Medical was founded in 2014. It employs 1 to 10 people.

Where is Butterfly Medical based?

Butterfly Medical is headquartered in Yoqne`am `illit, Israel, in the Middle East region.

How does Butterfly Medical make money?

One revenue line is on record: sale of implantable prostatic retraction device.

Who are Butterfly Medical's main competitors?

Emerging players on record are ProVerum, Zenflow and SRS Medical. Direct peers are Medifocus, PROCEPT BioRobotics, Laborie / Urotronic (Optilume BPH) and Teleflex (NeoTract / Urolift). Broad incumbents are Coloplast, Boston Scientific (Rezum / NxThera) and Olympus (iTind).

Does Butterfly Medical have an API?

No public API is recorded for Butterfly Medical.

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Live signals
Urology TimesPivotal trial of Butterfly Medical device for BPH reaches final completionButterfly Medical announced the successful completion of its pivotal randomized controlled trial for the Butterfly Prostatic Retraction Device, a minimally invasive treatment for benign prostatic hyperplasia (BPH). The study involved 244 patients and demonstrated the device's ability to restore urinary flow without tissue removal, with results expected to support an FDA premarket approval application. This milestone positions the device as a potential non-surgical alternative for men seeking relief from BPH symptoms.Mpo-magButterfly Medical Secures $21 Million in Upsized Series C FundingButterfly Medical completed a Series C funding round raising $21 million from investors including the European Innovation Council, Junson Capital, MedVenture, and New Rhein Healthcare Investors, exceeding its fundraising target. The company's non-surgical device for benign prostatic hyperplasia (BPH) has CE Mark approval in Europe, with U.S. regulatory filings currently under review. Butterfly Medical plans to use the funding to prepare for commercialization pending FDA approval.Medical Device NetworkButterfly Medical raises $21m in funds for BPH device developmentButterfly Medical has raised $21 million in Series C funding for the development and potential commercialisation of its CE-marked Butterfly prostatic retraction device for benign prostatic hyperplasia (BPH), with the round exceeding the company's target. The funding included participation from MedVenture, Junson Capital, European Innovation Council (EIC), and New Rhein Healthcare Investors. The company has completed its pivotal clinical trial and has US regulatory filings underway, with plans to present at the American Urological Association 2026 Annual Meeting in Washington.FinSMEsButterfly Medical Raises $21M in FundingButterfly Medical, a Yokneam, Israel-based medical device company developing a non-surgical solution for benign prostatic hyperplasia (BPH), raised $21M in Series C funding from investors including the European Innovation Council (EIC), Junson Capital, MedVenture, and New Rhein Healthcare Investors. The company plans to use the proceeds to expand operations and advance its development efforts. The company's flagship device is CE Mark certified but remains limited to investigational use in the United States pending FDA approval.citybizButterfly Medical Raises $21 Million to Advance Non-Surgical BPH Device Toward U.S. CommercializationButterfly Medical has raised $21 million in an oversubscribed Series C financing round to advance its implantable prostatic retraction device toward U.S. regulatory review and commercialization. The funding exceeded the company's original target with participation from investors including the European Innovation Council, Junson Capital, MedVenture, and New Rhein Healthcare Investors. The device has received CE Mark approval in Europe and regulatory submissions are currently under review by the FDA, with commercial preparation underway ahead of a potential U.S. launch.PR NewswireButterfly Medical Secures $21 Million in Upsized Series C Funding to Advance Minimally Invasive BPH TreatmentButterfly Medical, a medical device company developing a non-surgical treatment for benign prostatic hyperplasia (BPH), has raised $21 million in an oversubscribed Series C funding round with participation from institutional investors including the European Innovation Council, Junson Capital, MedVenture, and New Rhein Healthcare Investors. The company has completed its pivotal trial, has FDA regulatory filings in progress, and the device already holds CE Mark approval for use in Europe. Butterfly Medical is preparing for U.S. commercialization and will showcase its technology at the AUA 2026 Annual Meeting in Washington, D.C.MassDeviceButterfly Medical raises $21M for BPH deviceButterfly Medical raised $21 million in a Series C round to support its BPH treatment device. The company's minimally invasive prostatic retraction device aims to restore urinary flow without tissue removal. It now seeks FDA approval and global commercialization.Venture Capital Access OnlineButterfly Medical Secures $21 Million in Upsized Series C Funding to Advance Minimally Invasive BPH TreatmentButterfly Medical raised $21 million in a Series C round, exceeding its target, to advance its minimally invasive BPH treatment device. The company will showcase the device at AUA 2026, with U.S. regulatory filings underway and CE Mark approval already secured.MedCity NewsButterfly Medical Offers Non-Surgical Option to Treat Enlarged ProstateIsraeli company Butterfly Medical announced completion of the 12-month follow-up for all patients in its international pivotal clinical study of the Butterfly Prostatic Retraction device, a first-line interventional therapy for benign prostatic hyperplasia, with nearly 245 patients enrolled across 26 sites mostly in the U.S. The device, which is already approved in Europe, uses endoscopically-delivered nitinol implants to retract prostate tissue and restore urinary flow without cutting, burning, or removing tissue, offering an alternative to drugs like Flomax and invasive surgery. The company expects to submit the study data to the FDA in the coming months for premarket approval and plans to commercialize the device in 2027.PR NewswireButterfly Medical Announces Completion of Pivotal Trial for Minimally Invasive Treatment of Benign Prostatic HyperplasiaButterfly Medical announced the completion of the final 12-month follow-up for all 244 patients in its international pivotal clinical study evaluating the Butterfly Prostatic Retraction Device for benign prostatic hyperplasia (BPH) treatment. The results will support the company's planned FDA Pre-Market Approval (PMA) application, bringing the device one step closer to commercialization in the U.S. The device is already CE Mark approved in the European Union but remains investigational in the U.S., limited by federal law to investigational use.