| 2025/11/16 | 22:19:22 | Urocross Expander System Officially Submitted to the U.S. FDA for 510(k) Clearance | |
| SEQ_NO |
1 |
Date of announcement |
2025/11/16 |
Time of announcement |
22:19:22 |
| Subject |
Urocross Expander System Officially Submitted to the U.S. FDA for 510(k) Clearance |
| Date of events |
2025/11/14
|
To which item it meets |
paragraph 10 |
| Statement |
1.Date of occurrence of the event:2025/11/14
2.New drug name or code: Urocross Expander System
3.Indication:
The Urocross Expander System is a removable, non-permanent implant system
developed to improve lower urinary tract symptoms (LUTS) associated with
Benign Prostatic Hyperplasia (BPH). The system gently expands the prostatic
urethral tissue through a minimally invasive procedure performed under mild
anesthesia, thereby relieving obstruction and improving urinary flow.
4.Planned development stages:
The Urocross Expander System has been officially submitted for market
clearance to the U.S. FDA on 2025/11/13 (California time). Subsequent
actions will follow the FDA’s review procedures and timeline, with the
review period expected to take approximately three to six months.
5.Current development stage:
(1) Submission of application / approval granted / approval not granted /
results of each phase of clinical trials (including interim analysis)
/ occurrence of other material events affecting new drug development:
The Urocross Expander System has been officially submitted for market
clearance to the U.S. FDA.
(2) In the event that approval is not granted by the competent authority
for the intended use, or the results of any phase of clinical trials
(including interim analysis) fail to reach statistical significance,
or other material events occur that may affect new drug development,
the risks faced by the Company and corresponding countermeasures:
Not Applicable
(3) In the event that approval has been granted by the competent authority
for the intended use, or the results of any phase of clinical trials
(including interim analysis) reach statistical significance, or other
material events occur that may affect new drug development, the
Company’s future business plans and directions: Not Applicable
(4) Cumulative research and development expenses incurred?G
Due to the involvement of information pertaining to future
international licensing negotiations, and to avoid impacting the
licensing amount while safeguarding the rights and interests of
investors, the details will not be disclosed at this time.
6.Upcoming development plan:
Subsequent actions will follow the FDA’s review procedures and timeline,
with the review period expected to take approximately three to six months.
7.Market situation:
The probability of men suffering from BPH increases with age. The estimated
population in only the United States with BPH is reaching 40 million. As
the population continues to age, the number of BPH patients is expected to
grow accordingly. According to a market research report by Grand View
Research published in 2023, the global market for medical devices treating
BPH reached USD 1.42 billion in 2022. It is projected that from 2023 to
2030, the BPH-related market will grow at a compound annual growth rate
(CAGR) of 8.9%.
8.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 8
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.):
The clinical data obtained aligns with the preliminary clinical results
announced in May 2025, showing no change in the overall trend. Based on the
typical review timeline for historical 510(k) applications, the review
period is estimated to be approximately three to six months. However, the
full impact of the schedule resulting from the resumption following the
U.S. government shutdown is currently difficult to assess completely. The
Company will make disclosure in the event of material changes to the review
progress or outcome according to relevant laws and regulations. Should the
review proceed smoothly, preparations for U.S. market commercialization can
commence; however, the actual impact will ultimately depend on the FDA’s
final review results and market adoption progress.
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.: |
|
| 2025/11/06 | 16:59:54 | Medeon Board of Directors approved the 2025Q3 consolidated financial reports | |
| SEQ_NO |
1 |
Date of announcement |
2025/11/06 |
Time of announcement |
16:59:54 |
| Subject |
Medeon Board of Directors approved the 2025Q3 consolidated financial reports |
| Date of events |
2025/11/06
|
To which item it meets |
paragraph 31 |
| Statement |
1.Date of the board of directors submitted or approved:2025/11/06
2.Date of the audit committee approved:2025/11/06
3.Start and end dates of financial reports or unaudited financial
information of the reporting period(XXXX/XX/XX~XXXX/XX/XX):
2025/01/01~2025/09/30
4.Operating revenue accumulated from 1/1 to end of the period
(thousand NTD):304,555
5.Gross profit (loss) from operations accumulated from 1/1 to end of
the period (thousand NTD):36,826
6.Net operating income (loss) accumulated from 1/1 to end of the period
(thousand NTD):(562,249)
7.Profit (loss) before tax accumulated from 1/1 to end of the period
(thousand NTD):(565,036)
8.Profit (loss) accumulated from 1/1 to end of the period
(thousand NTD):(564,849)
9.Profit (loss) during the period attributable to owners of parent
accumulated from 1/1 to end of the period (thousand NTD):(530,947)
10.Basic earnings (loss) per share accumulated from 1/1 to end of
the period (NTD):(5.76)
11.Total assets end of the period (thousand NTD):1,519,559
12.Total liabilities end of the period
(thousand NTD):268,549
13.Equity attributable to owners of parent end of the
period (thousand NTD):1,173,408
14.Any other matters that need to be specified:None |
|
| 2025/10/29 | 16:15:22 | Announcement of the Board of Directors Meeting Date for Approval of the Third-Quarter 2025 Financial Report | |
| SEQ_NO |
1 |
Date of announcement |
2025/10/29 |
Time of announcement |
16:15:22 |
| Subject |
Announcement of the Board of Directors Meeting Date for Approval of the Third-Quarter 2025 Financial Report |
| Date of events |
2025/10/29
|
To which item it meets |
paragraph 31 |
| Statement |
1.Date of a notice of the board of directors meeting is issued:2025/10/29
2.Expected date of the board of directors meeting is convened:2025/11/06
3.Expected year and quarter of the financial reports
or the annual self-assessed financial information
submitted to the board of directors or approved by
the board of directors: Third-Quarter 2025
4.Any other matters that need to be specified:None |
|
| 2025/10/17 | 16:03:25 | The Company has been required by TPEx to announce the financial data according to the regulations. | |
| SEQ_NO |
1 |
Date of announcement |
2025/10/17 |
Time of announcement |
16:03:25 |
| Subject |
The Company has been required by TPEx to announce the financial data according to the regulations. |
| Date of events |
2025/10/15
|
To which item it meets |
paragraph 53 |
| Statement |
1.Date of occurrence of the event: 2025/10/15
2.Cause of occurrence:Announced as required by the TPEx
3.Financial and business information:
Unit: (NT$million)
(1) Monthly
Sep 2025 Sep 2024 YoY Change %
—————————————————————————
Sales revenue 37.760 23.838 58.40%
Loss before income tax (70.962) (81.925) 13.38%
Net Loss attributable to
Owners of the parent (66.936) (76.322) 12.30%
EPS (NT$) (0.73) (0.83) 12.30%
(Losses reduced)
===========================================================================
(2)Quarterly
Q2 2025 Q2 2024 YoY Change %
—————————————————————————
Sales revenue 110.382 63.526 73.76%
Loss before income tax (188.238) (216.085) 12.89%
Net Loss attributable to
Owners of the parent (178.160) (212.458) 16.14%
EPS (NT$) (1.93) (2.31) 16.45%
(Losses reduced)
===========================================================================
(3)Cumulative for the last four seasons
Latest 4 quarters accumulation
(Q3 2024 to Q2 2025)
—————————————————————————
Revenue 394.401
Loss before income tax (806.853)
Net Loss attributable to
Owners of the parent (749,380)
EPS (NT$) (8.12)
===========================================================================
4.Any material information that needs to be specified
according to Article 4 of Taipei Exchange Procedures
for Verification and Disclosure of Material Information
of Companies with TPEx Listed Securities:
Medeon has disclosed material information titled ‘Urocross Retrieval
Sheath Receives FDA 510(k) Clearance as the First Approved Accessory
to the Urocross Expander System’ in accordance with Article 53 over
the past six business days.
5.Any material information in a press conference listed
under Article 11 of Taipei Exchange Procedures for
Verification and Disclosure of Material Information of
Companies with TPEx Listed Securities:
Medeon has not held any press conferences to explain material information
in the past six business days.
6.Any other matters that need to be specified:
(1)The aforementioned financial information for June 2025 and its YOY
comparison consists in the consolidated reviewed amounts prepared by
the Company adopting the IFRS, and has not been audited (reviewed)
by CPA; it is only for reference by investors.
(2)The information for the latest quarter (Q2 2025) refers to single
quarter amounts, not cumulative amounts from the latest financial
reports, and are consolidated amounts prepared under the IFRS,
which have been audited (reviewed) by CPA; it is only for reference
by investors.
(3)The information accumulated over the last 4 quarters consists in the
consolidated amounts from Q3 2024 to Q2 2025 prepared by the Company
adopting the IFRS, and has been audited (reviewed) by CPA; it is only
for reference by investors. |
|
| 2025/10/15 | 17:10:11 | Announcement on Matters Relating to the Record Date for the Company’s 2025 Cash Capital Increase (Supplements: Issue Price and Bank) | |
| SEQ_NO |
1 |
Date of announcement |
2025/10/15 |
Time of announcement |
17:10:11 |
| Subject |
Announcement on Matters Relating to the Record Date for the Company’s 2025 Cash Capital Increase (Supplements: Issue Price and Bank) |
| Date of events |
2025/10/15
|
To which item it meets |
paragraph 11 |
| Statement |
1.Date of the board of directors resolution or decision
by the Company for record date:2025/10/15
2.Whether to adopt shelf registration (Yes, please state issuance period /No):
No
3.Effective registration date approved by competent authority:2025/10/02
4.Date of the board of directors resolution for (additional) issuance
of shares:2025/09/01
5.Total monetary value of the issuance and number of shares issued:
Issuance Amount: NT$47,000,000
Number of Shares Issued: 4,700,000 common shares
6.If adopting shelf registration, monetary value and number of shares
to be issued this time:NA
7.The remaining monetary value and shares after this issuance when
adopting shelf registration:NA
8.Par Value per share:NT$10
9.Issue price:NT$90 per share.
10.Number of shares subscribed for by employees:
In accordance with Article 267 of the Company Act, 15% of the total
shares to be issued, amounting to 705,000 shares, shall be reserved for
subscription by the Company’s employees.
11.Ratio of shares subscribed for by existing shareholders:
75% of the newly issued shares shall be subscribed by shareholders
listed in the shareholders’ register on the subscription record date,
in proportion to their respective shareholdings.
12.Method for public sale and no.of shares:
In accordance with Article 28-1 of the Securities and Exchange Act, 10%
of the total issued shares shall be allocated for public offering.
13.Handling method for fractional shares and shares unsubscripted for by the
deadline:
Fractional shares resulting from subscriptions of less than one full
share may be combined into whole shares by shareholders directly with
the Company’s stock transfer agent within five days from the suspension
of share transfer. Shares that are forfeited by existing shareholders or
employees who waive their subscription rights, or any remaining
fractional shares, are hereby authorized to be subscribed by the
Chairman, on behalf of the Company, by designated persons at the
issuance price.
14.Rights and obligations of these newly issued shares:
The new shares issued in this cash capital increase will be issued in
dematerialized form and shall carry the same rights and obligations as
the existing shares.
15.Utilization of the funds from the current capital increase:
Investment in subsidiaries
16.Record date of cash capital increase and share subscription: 2025/10/30
17.Last date before book closure:2025/10/25
18.Book closure starting date:2025/10/26
19.Book closure ending date:2025/10/30
20.Payment period:
(1) Existing shareholders or employees: 2025/11/05~2025/12/05
(2) Designated persons: 2025/12/08-2025/12/16
21.Date of the agreement with the banks to collect and deposit the proceeds:
2025/10/15
22.Name of the institution designated to collect the proceeds:
The Shanghai Commercial & Savings Bank, Ltd., San Chung Branch
23.Name of the bank designated to deposit the proceeds:
The Shanghai Commercial & Savings Bank, Ltd., North Chung Ho Branch
24.Any other matters that need to be specified:
The key details of this cash capital increase plan include the source of
funds, planned projects, expected schedule, and anticipated benefits.
Should there be any amendments required by the competent authority, any
matters not fully addressed, or changes necessitated by objective
circumstances, the Company intends to request the Board of Directors to
authorize the Chairman to handle such matters with full discretion. If
the actual issuance price per share is adjusted due to market
fluctuations and results in a shortfall in the funds to be raised, the
shortfall shall be covered by the Company’s own funds. Conversely, if
the funds raised exceed the target, the surplus shall be used to
strengthen the Company’s operating capital. |
|
| 2025/10/08 | 22:16:51 | Urocross Retrieval Sheath Receives FDA 510(k) Clearance as the First Approved Accessory to the Urocross Expander System | |
| SEQ_NO |
1 |
Date of announcement |
2025/10/08 |
Time of announcement |
22:16:51 |
| Subject |
Urocross Retrieval Sheath Receives FDA 510(k) Clearance as the First Approved Accessory to the Urocross Expander System |
| Date of events |
2025/10/08 |
To which item it meets |
paragraph 10 |
| Statement |
1.Date of occurrence of the event:2025/10/08
2.New drug name or code:
Urocross Retrieval Sheath (Prodeon Urethral Sheath System)
3.Indication:
The Urocross Retrieval Sheath is an accessory device designed for use
with the Urocross Expander System. It is compatible with standard
flexible cystoscopes and enables the safe retrieval of the implant
approximately six months after placement. The device can also be used to
establish a conduit as an operative passage during the treatment of
urinary stones or other urinary diseases during endoscopic urological
procedures.
(Note: The Urocross Expander System is a removable, non-permanent implant
system developed to improve lower urinary tract symptoms (LUTS)
associated with Benign Prostatic Hyperplasia (BPH). The system
gently expands the prostatic urethral tissue through a minimally
invasive procedure performed under mild anesthesia, thereby
relieving obstruction and improving urinary flow. The implant is
intended to be removed after six months with the aforementioned
Retrieval Sheath, ensuring that no permanent implant remains.)
4.Planned development stages:
Urocross Retrieval Sheath has obtained an independent FDA 510(k)
clearance as the retrieval accessory for the Urocross Expander System,
and will be marketed for use in conjunction with the Urocross Expander
System. The Urocross Expander System is planned to be formally submitted
to the US FDA for market clearance in 2025Q4, as previously communicated.
5.Current development stage:
(1)Submission of application / approval granted / approval not granted /
results of each phase of clinical trials (including interim analysis)
/ occurrence of other material events affecting new drug development:
Urocross Retrieval Sheath Receives FDA 510(k) Clearance as the First
Approved Accessory to the Urocross Expander System
(2)In the event that approval is not granted by the competent authority
for the intended use, or the results of any phase of clinical trials
(including interim analysis) fail to reach statistical significance,
or other material events occur that may affect new drug development,
the risks faced by the Company and corresponding countermeasures:
Not Applicable
(3)In the event that approval has been granted by the competent authority
for the intended use, or the results of any phase of clinical trials
(including interim analysis) reach statistical significance, or other
material events occur that may affect new drug development, the
Company’s future business plans and directions:
Not Applicable
(4)Cumulative research and development expenses incurred:
Due to the involvement of information pertaining to future
international licensing negotiations, and to avoid impacting the
licensing amount while safeguarding the rights and interests of
investors, the details will not be disclosed at this time.
6.Upcoming development plan:
The main system, Urocross Expander System, is planned to be formally
submitted to the US FDA for market clearance in 2025Q4, and the
development progress remains on track as originally planned.
7.Market situation:
The probability of men suffering from BPH increases with age. The
estimated population in only the United States with BPH is reaching 40
million. As the population continues to age, the number of BPH patients
is expected to grow accordingly. According to a market research report by
Grand View Research published in 2023, the global market for medical
devices treating BPH reached USD 1.42 billion in 2022. It is projected
that from 2023 to 2030, the BPH-related market will grow at a compound
annual growth rate (CAGR) of 8.9%.
8.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 8
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.)
This announcement is to inform that Urocross Retrieval Sheath, designed
for use with the Urocross Expander System, has successfully received US
FDA 510(k) clearance as the first approved accessory. The Urocross
Expander System is scheduled for formal submission to the US FDA in
2025Q4, with development progressing as planned. The Company will
continue to make relevant disclosures in compliance with applicable laws
and regulations.
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation. |
|
| 2025/10/07 | 20:32:48 | Announcement of Change in the Company’s Acting Spokesperson | |
| SEQ_NO |
1 |
Date of announcement |
2025/10/07 |
Time of announcement |
20:32:48 |
| Subject |
Announcement of Change in the Company's Acting Spokesperson |
| Date of events |
2025/10/07
|
To which item it meets |
paragraph 8 |
| Statement |
1.Type of personnel changed (please enter:
spokesperson, acting spokesperson, important
personnel (CEO, COO, CMO, CSO, etc.), financial
officer, accounting officer, corporate governance
officer, chief information security officer,research
and development officer, internal audit officer, or
designated and non-designated representatives): Acting Spokesperson
2.Date of occurrence of the change: 2025/10/07
3.Name, title, and resume of the previous position holder:
Pearl Ling / Assistant Manager of Finance & Business Analysis
4.Name, title, and resume of the new position holder:
Greta Chang / Executive VP
5.Type of change (please enter: ‘resignation’,
‘position adjustment’, ‘dismissal’, ‘retirement’,
‘death’ or ‘new replacement’): Resignation/New replacement
6.Reason for the change: Due to personal reasons
7.Effective date: 2025/10/07
8.Any other matters that need to be specified: N/A |
|
| 2025/10/03 | 16:10:56 | Announcement on Matters Relating to the Record Date for the Company’s 2025 Cash Capital Increase | |
| SEQ_NO |
1 |
Date of announcement |
2025/10/03 |
Time of announcement |
16:10:56 |
| Subject |
Announcement on Matters Relating to the Record Date for the Company’s 2025 Cash Capital Increase |
| Date of events |
2024/10/03
|
To which item it meets |
paragraph 11 |
| Statement |
1.Date of the board of directors resolution or decision
by the Company for record date:2024/10/03
2.Whether to adopt shelf registration (Yes, please state issuance period /No):
No
3.Effective registration date approved by competent authority:2025/10/02
4.Date of the board of directors resolution for (additional) issuance
of shares:2024/09/01
5.Total monetary value of the issuance and number of shares issued:
Issuance Amount: NT$47,000,000
Number of Shares Issued: 4,700,000 common shares
6.If adopting shelf registration, monetary value and number of shares
to be issued this time:NA
7.The remaining monetary value and shares after this issuance when
adopting shelf registration:NA
8.Par Value per share:NT$10
9.Issue price:
The actual issuance price shall be determined by the Chairman, upon
approval of the competent authority, in consultation with the lead
underwriter and in accordance with Article 6 of the ‘Self-Regulation
Rules for Securities Underwriters Assisting Companies in Offering and
Issuing Securities’ of the ROC Securities Association and other
applicable laws and regulations.
10.Number of shares subscribed for by employees:
In accordance with Article 267 of the Company Act, 15% of the total
shares to be issued, amounting to 705,000 shares, shall be reserved for
subscription by the Company’s employees.
11.Ratio of shares subscribed for by existing shareholders:
75% of the newly issued shares shall be subscribed by shareholders
listed in the shareholders’ register on the subscription record date,
in proportion to their respective shareholdings.
12.Method for public sale and no.of shares:
In accordance with Article 28-1 of the Securities and Exchange Act, 10%
of the total issued shares shall be allocated for public offering.
13.Handling method for fractional shares and shares unsubscripted for by the
deadline:
Fractional shares resulting from subscriptions of less than one full
share may be combined into whole shares by shareholders directly with
the Company’s stock transfer agent within five days from the suspension
of share transfer. Shares that are forfeited by existing shareholders or
employees who waive their subscription rights, or any remaining
fractional shares, are hereby authorized to be subscribed by the
Chairman, on behalf of the Company, by designated persons at the
issuance price.
14.Rights and obligations of these newly issued shares:
The new shares issued in this cash capital increase will be issued in
dematerialized form and shall carry the same rights and obligations as
the existing shares.
15.Utilization of the funds from the current capital increase:
Investee subsidiary
16.Record date of cash capital increase and share subscription: 2025/10/30
17.Last date before book closure:2025/10/25
18.Book closure starting date:2025/10/26
19.Book closure ending date:2025/10/30
20.Payment period:
(1) Existing shareholders or employees: 2025/11/05~2025/12/05
(2) Designated persons: 2025/12/08-2025/12/16
21.Date of the agreement with the banks to collect and deposit the proceeds:
An announcement will be made separately upon execution of the agreement.
22.Name of the institution designated to collect the proceeds:
An announcement will be made separately upon execution of the agreement.
23.Name of the bank designated to deposit the proceeds:
An announcement will be made separately upon execution of the agreement.
24.Any other matters that need to be specified:
The key details of this cash capital increase plan include the source of
funds, planned projects, expected schedule, and anticipated benefits.
Should there be any amendments required by the competent authority, any
matters not fully addressed, or changes necessitated by objective
circumstances, the Company intends to request the Board of Directors to
authorize the Chairman to handle such matters with full discretion. If
the actual issuance price per share is adjusted due to market
fluctuations and results in a shortfall in the funds to be raised, the
shortfall shall be covered by the Company’s own funds. Conversely, if
the funds raised exceed the target, the surplus shall be used to
strengthen the Company’s operating capital. |
|
| 2025/09/24 | 16:46:15 | Medeon, on behalf of its subsidiary PMC, announces Cash Capital Increase: Waiver by All Directors and Subscription by Specific Parties | |
| SEQ_NO |
2 |
Date of announcement |
2025/09/24 |
Time of announcement |
16:46:15 |
| Subject |
Medeon, on behalf of its subsidiary PMC, announces Cash Capital Increase: Waiver by All Directors and Subscription by Specific Parties |
| Date of events |
2025/09/24
|
To which item it meets |
paragraph 45 |
| Statement |
1.Date of occurrence of the event:2025/09/24
2.Reason for the forfeiture of subscription rights by the
directors nd supervisors:
PMC has entered the commercialization and stage. To strengthen its global
presence and accelerate strategic collaborations, the Company intends to
bring in strategic investors with international resources. In light of
the current global capital market uncertainties and in alignment with the
Medeon’s overall financial planning, the Board of Directors has resolved
to forgo participation in this cash capital increase.
3.Name of director/supervisor, number of shares forfeited,
and the percentage out of total subscription:
Director?GMedeon Biodesign, Inc.
Number of shares forfeited: 2,856,017 shares
The percentage out of total subscription: 100%
4.Name(s) of the specific person(s) and no.of shares subscribed:
Pursuant to the authorization of PMC’s Board of Directors, the Chairman
of PMC is authorized to negotiate with specific parties for the
subscription
5.Any other matters that need to be specified:None. |
|
| 2025/09/24 | 16:42:51 | Medeon’s Board of Directors resolved to waive participation in PMC’s cash capital increase. | |
| SEQ_NO |
1 |
Date of announcement |
2025/09/24 |
Time of announcement |
16:42:51 |
| Subject |
Medeon’s Board of Directors resolved to waive participation in PMC’s cash capital increase. |
| Date of events |
2025/09/24
|
To which item it meets |
paragraph 53 |
| Statement |
1.Date of occurrence of the event:2025/09/24
2.Company name:Medeon Biodesign, Inc.
3.Relationship to the Company (please enter ‘head office’ or
‘subsidiaries’):head office
4.Reciprocal shareholding ratios:NA
5.Cause of occurrence:PMC has entered the commercialization stage.
To strengthen its global presence and accelerate strategic
collaborations, the Company intends to bring in strategic investors with
international resources. In light of the current global capital market
uncertainties and in alignment with the Medeon’s overall financial
planning, the Board of Directors has resolved to forgo participation in
this cash capital increase.
6.Countermeasures:
Pursuant to the authorization of PMC’s Board of Directors, the Chairman
of PMC is authorized to negotiate with specific parties for the
subscription.
7.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 9
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.):None. |
|
