| 2026/11/04 | 16:12:45 | Urocross Expander System Officially Obtained the Market Approval from TFDA | |
| SEQ_NO |
1 |
Date of announcement |
2026/11/04 |
Time of announcement |
16:12:45 |
| Subject |
Urocross Expander System Officially Obtained the Market Approval from TFDA |
| Date of events |
2026/11/04
|
To which item it meets |
paragraph 10 |
| Statement |
1.Date of occurrence of the event:2026/11/04
2.New drug name or code:Urocross Expander System
3.Indication:
The Urocross Expander System is a retrievable, 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 officially obtained the market approval
from TFDA on 2026/11/4 (Taipei Time).
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 officially obtained the market
approval from TFDA
(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 global
business development discussions, and to avoid impacting the deal
amount while safeguarding the rights and interests of investors, the
details will not be disclosed at this time.
6.Upcoming development plan:
Subsequent efforts will continue to advance preparations for product
launch while simultaneously conducting international strategic
collaboration discussions.
7.Market situation:
The probability of men suffering from BPH increases with age;
approximately half of men aged 60 have histologically confirmed prostate
hyperplasia, and this figure rises to 70% to 80% among men aged 70 and
older. The estimated population in the United States alone with BPH is
reaching 40 million. As the population continues to age, the number of BPH
patients is expected to grow accordingly. According to statistics from the
National Health Insurance under Taiwan Ministry of Health and Welfare, the
number of people seeking medical treatment for benign prostatic
hyperplasia in Taiwan exceeded 800 thousand in 2025, indicating a
significant level of medical demand for this condition. According to a
market research report by Grand View Research, the global market for
medical devices treating BPH reached USD 1.67 billion in 2024. It is
projected that from 2025 to 2033, the BPH-related market will grow at a
compound annual growth rate (CAGR) of 9.4%, reaching USD 3.71 billion in
2033.
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 Company has successfully obtained the market approval from TFDA,
enabling it to legally commence sales activities in the Taiwan market. The
team will continue to advance preparations for introducing Urocross into
Taiwan’s healthcare system, while progressing key initiatives related to
product supply, distribution channels, and professional education and
training. Through comprehensive market readiness efforts, the team aims to
enhance healthcare professionals’ understanding of the product’s
characteristics and supporting clinical evidence, while taking a measured,
step-by-step approach to establishing a solid foundation for its adoption
in Taiwan’s healthcare enviroment.
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.: |
|
| 2026/09/20 | 23:44:26 | Medeon has entered into the Cross-Seal Settlement and Termination Agreement with Terumo | |
| SEQ_NO |
1 |
Date of announcement |
2026/09/20 |
Time of announcement |
23:44:26 |
| Subject |
Medeon has entered into the Cross-Seal Settlement and Termination Agreement with Terumo |
| Date of events |
2026/09/20
|
To which item it meets |
paragraph 53 |
| Statement |
1.Date of occurrence of the event:2026/09/20
2.Company name:Medeon Biodesign, Inc.
3.Relationship to the Company (please enter ‘head office’ or
‘subsidiaries’):Head Office
4.Reciprocal shareholding ratios:Not Applicable
5.Cause of occurrence:
Since the Company executed the Cross-Seal Asset Purchase Agreement with
Terumo in March 2018, both parties have maintained a friendly and close
collaborative relationship. However, due to the impact of the pandemic and
supply chain challenges during this period, the launch schedule for
Cross-Seal was delayed, making it difficult to achieve the original
objectives. Consequently, Terumo issued a ‘Milestone Abandonment Notice’
in May 2025, resulting in the discontinuation of this project under the
Agreement.
Since May 2025, both parties actively sought constructive and mutually
beneficial solutions, while maintaining a strong working relationship and
communication foundation to sustain flexibility for future collaborations.
After one year and four months of discussions, the parties have reached a
final agreement that Medeon will receive a settlement amount of $6 million
US Dollars, all milestones specified in the Asset Purchase Agreement will
then be abandoned, and the relevant service agreements will be terminated.
The milestone payments previously received were for milestones already
achieved and are therefore non-refundable.
6.Countermeasures:To publish this announcement.
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.):
The Company has not previously recognized revenue for milestones that have
not yet been achieved, and will then recognize revenue in accordance with
relevant accounting standards. |
|
| 2026/09/18 | 15:15:08 | The Board of Medeon has approved the execution of the Cross-Seal Settlement and Termination Agreement with Terumo | |
| SEQ_NO |
1 |
Date of announcement |
2026/09/18 |
Time of announcement |
15:15:08 |
| Subject |
The Board of Medeon has approved the execution of the Cross-Seal Settlement and Termination Agreement with Terumo |
| Date of events |
2026/09/18
|
To which item it meets |
paragraph 53 |
| Statement |
1.Date of occurrence of the event:2026/09/18
2.Company name:Medeon Biodesign, Inc.
3.Relationship to the Company (please enter ‘head office’ or
‘subsidiaries’):Head Office
4.Reciprocal shareholding ratios:Not Applicable
5.Cause of occurrence:
Since the Company executed the Cross-Seal Asset Purchase Agreement with
Terumo in March 2018, both parties have maintained a friendly and close
collaborative relationship. However, due to the impact of the pandemic and
supply chain challenges during this period, the launch schedule for Cross-
Seal was delayed, making it difficult to achieve the original objectives.
Consequently, Terumo issued a ‘Milestone Abandonment Notice’ in May
2025, resulting in the discontinuation of this project under the
Agreement.
Since May 2025, both parties actively sought constructive and mutually
beneficial solutions, while maintaining a strong working relationship and
communication foundation to sustain flexibility for future collaborations.
After one year and four months of discussions, the parties have reached a
final agreement that Medeon will receive a settlement amount of $6 million
US Dollars, all milestones specified in the Asset Purchase Agreement will
then be abandoned, and the relevant service agreements will be terminated.
The milestone payments previously received were for milestones already
achieved and are therefore non-refundable.
6.Countermeasures:To publish this announcement.
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.):
The Company has not previously recognized revenue for milestones that have
not yet been achieved; upon completion of the settlement agreement, the
Company will then recognize revenue in accordance with relevant accounting
standards. |
|
| 2026/08/26 | 14:49:42 | Medeon is invited to attend the investor conference held by Taishin Securities | |
| SEQ_NO |
2 |
Date of announcement |
2026/08/26 |
Time of announcement |
14:49:42 |
| Subject |
Medeon is invited to attend the investor conference held by Taishin Securities |
| Date of events |
2026/08/27
|
To which item it meets |
paragraph 12 |
| Statement |
1.Date of institutional investor conference:2026/08/27
2.Time of institutional investor conference:14:30
3.Location of institutional investor conference:
11F., No. 97, Sec. 2, Dunhua S. Rd., Taipei City (Education and Training
Room, 11F, Tunnan Tower)
4.Outline of institutional investor conference:
The Company is invited to attend the investor conference held by Taishin
Securities to outline an overview of the Company’s current operational
status and future development plans.
5.Any other matters that need to be specified:None |
|
| 2026/08/26 | 12:48:47 | Explanation of Media Reports | |
| SEQ_NO |
1 |
Date of announcement |
2026/08/26 |
Time of announcement |
12:48:47 |
| Subject |
Explanation of Media Reports |
| Date of events |
2026/08/26
|
To which item it meets |
paragraph 53 |
| Statement |
1.Date of occurrence of the event:2026/08/26
2.Company name:Medeon Biodesign, Inc.
3.Relationship to the Company (please enter ‘head office’ or
‘subsidiaries’):head office
4.Reciprocal shareholding ratios:N/A
5.Name of the reporting media:
Economic Daily News, Page C05 / Commercial Times, Page B06
6.Content of the report:
August 26, 2026, Economic Daily News reported: ‘Urocross, a minimally
invasive BPH treatment device developed by the innovative medical device
company Medeon (6499), successfully received 510(k) clearance from the
U.S. FDA in March this year. Chairman Dr. Yue-Teh Jang stated yesterday
(the 25th) that the company has submitted an application for market
approval in Taiwan to the relevant regulatory authorities, with the goal
of obtaining approval by the end of the year.’
August 26, 115, Commercial Times report: ‘Medeon (6499) is entering a
critical turning point in its operations. Chairman Dr. Yue-Teh Jang stated
that, following U.S. FDA approval of Urocross, the minimally invasive BPH
treatment device, the company is moving into the commercialization phase
and will adopt a dual-track strategy of ‘commercialization and out-
licensing’ at this stage. Meanwhile, its application for market approval
in Taiwan is currently under review, with the company striving to obtain
approval this year.’
7.Cause of occurrence:Explanation of Media Reports
8.Countermeasures:
The Company has submitted the application for market approval in Taiwan
for Urocross, the minimally invasive BPH treatment device. Further
progress will be made in accordance with the review procedures of the
Taiwan Food and Drug Administration (TFDA).
9.Any other matters that need to be specified:None |
|
| 2026/08/07 | 15:22:18 | Medeon Board of Directors approved the 2026Q2 consolidated financial reports | |
| SEQ_NO |
1 |
Date of announcement |
2026/08/07 |
Time of announcement |
15:22:18 |
| Subject |
Medeon Board of Directors approved the 2026Q2 consolidated financial reports |
| Date of events |
2026/08/07
|
To which item it meets |
paragraph 31 |
| Statement |
1.Date of the board of directors submitted or approved:2026/08/07
2.Date of the audit committee approved:2026/08/07
3.Start and end dates of financial reports or unaudited financial
information of the reporting period(XXXX/XX/XX~XXXX/XX/XX):
2026/01/01~2026/06/30
4.Operating revenue accumulated from 1/1 to end of the period
(thousand NTD):220,900
5.Gross profit (loss) from operations accumulated from 1/1 to end of
the period (thousand NTD):29,270
6.Net operating income (loss) accumulated from 1/1 to end of the period
(thousand NTD):(271,616)
7.Profit (loss) before tax accumulated from 1/1 to end of the period
(thousand NTD):(273,869)
8.Profit (loss) accumulated from 1/1 to end of the period
(thousand NTD):(273,892)
9.Profit (loss) during the period attributable to owners of parent
accumulated from 1/1 to end of the period (thousand NTD):(246,623)
10.Basic earnings (loss) per share accumulated from 1/1 to end of
the period (NTD):(2.54)
11.Total assets end of the period (thousand NTD):1,551,305
12.Total liabilities end of the period
(thousand NTD):282,140
13.Equity attributable to owners of parent end of the
period (thousand NTD):1,229,775
14.Any other matters that need to be specified:None |
|
| 2026/07/30 | 17:04:33 | Announcement of the Board of Directors Meeting Date for Approval of the Second-Quarter 2026 Financial Report | |
| SEQ_NO |
1 |
Date of announcement |
2026/07/30 |
Time of announcement |
17:04:33 |
| Subject |
Announcement of the Board of Directors Meeting Date for Approval of the Second-Quarter 2026 Financial Report |
| Date of events |
2026/07/30
|
To which item it meets |
paragraph 31 |
| Statement |
1.Date of a notice of the board of directors meeting is issued:2026/07/30
2.Expected date of the board of directors meeting is convened:2026/08/07
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: Second-Quarter 2026
4.Any other matters that need to be specified:None |
|
| 2026/06/25 | 16:10:52 | Medeon approved to release Directors and its representatives from Non-Competition Restrictions at the Annual Shareholders’ Meeting | |
| SEQ_NO |
2 |
Date of announcement |
2026/06/25 |
Time of announcement |
16:10:52 |
| Subject |
Medeon approved to release Directors and its representatives from Non-Competition Restrictions at the Annual Shareholders' Meeting |
| Date of events |
2026/06/25
|
To which item it meets |
paragraph 21 |
| Statement |
1.Date of the shareholders’ meeting resolution:2026/06/25
2.Name and title of the managerial officer with permission
to engage in competitive conduct:
CENTER LABORATORIES INC. ; Director
Legal Representative of CENTER LABORATORIES INC., Jung Chin Lin; Director
3.Items of competitive conduct in which the officer is
permitted to engage:
Invest in or manage other companies with the same or similar scope of
business as Medeon Biodesign, Inc.
4.Period of permission to engage in the competitive conduct:
During the period of serving as director of Medeon Biodesign, Inc.
5.Circumstances of the resolution (please describe the
results of voting in accordance with Article 209 of the
Company Act):
Shares represented at the time of voting: 50,881,799 rights
Number of voting rights of shareholders present at the time of voting
Votes in favor 48,766,063 votes?APercentage of the total represented
share present 95.84%
Votes against 447,577 votes?APercentage of the total represented
share present 0.87%
Votes invalid 0 votes?APercentage of the total represented
share present 0.00%
Votes abstained 1,668,159 votes?APercentage of the total represented
share present 3.27%
6.If the permitted competitive conduct belongs to the
operator of a mainland China enterprise, the name and
title of the directors (if it is not the operator of
a mainland China enterprise, please enter ‘N/A’ below): N/A
7.Company name of the mainland China enterprise and the
officer’s position in the enterprise: N/A
8.Address of the mainland China enterprise: N/A
9.Operations of the mainland China enterprise: N/A
10.Impact on the company’s finance and business: N/A
11.If the directors have invested in the mainland China
enterprise, the monetary amount of the investment and
their shareholding ratio: N/A
12.Any other matters that need to be specified: None |
|
| 2026/06/25 | 16:00:42 | Announcement for the material resolutions at the 2026 Annual Shareholders’ Meeting. | |
| SEQ_NO |
1 |
Date of announcement |
2026/06/25 |
Time of announcement |
16:00:42 |
| Subject |
Announcement for the material resolutions at the 2026 Annual Shareholders’ Meeting. |
| Date of events |
2026/06/25
|
To which item it meets |
paragraph 18 |
| Statement |
1.Date of the shareholders’ meeting:2026/06/25
2.Important resolutions I.Profit distribution/deficit compensation:
Ratification of 2026 deficit offset proposal
3.Important resolutions II.Amendments of the company charter:None
4.Important resolutions III.Business report and financial statements:
Ratification of 2025 Business Report and Financial Statements
5.Important resolutions IV.Election for directors and supervisors:None
6.Important resolutions V.Other matters:
(1) Approval of the proposal for the private placement to issue
additional common shares
(2) Approval of the amendment of the Company’s ‘Procedures for
Acquisition or Disposal of Assets’
(3) Approval of the release of directors or its representatives from
Non-Competition Restrictions.
7.Any other matters that need to be specified:None |
|
| 2026/05/29 | 15:07:23 | Announcement for the important resolutions at the 2026 Annual Shareholders’ Meeting on behalf of Medeon’s major subsidiary, PMC | |
| SEQ_NO |
2 |
Date of announcement |
2026/05/29 |
Time of announcement |
15:07:23 |
| Subject |
Announcement for the important resolutions at the 2026 Annual Shareholders’ Meeting on behalf of Medeon’s major subsidiary, PMC |
| Date of events |
2026/05/29
|
To which item it meets |
paragraph 18 |
| Statement |
1.Date of the shareholders’ meeting:2026/05/29
2.Important resolutions I.Profit distribution/deficit compensation:
Ratification of 2025 deficit offset proposal
3.Important resolutions II.Amendments of the company charter:None
4.Important resolutions III.Business report and financial statements:
Ratification of 2025 Business Report and Financial Statements
5.Important resolutions IV.Election for directors and supervisors:None
6.Important resolutions V.Other matters:None
7.Any other matters that need to be specified:None |
|
