Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2011.
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| Format: | Thesis |
| Language: | eng |
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Massachusetts Institute of Technology
2011
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| Online Access: | http://hdl.handle.net/1721.1/65522 |
| _version_ | 1826192106845110272 |
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| author | Kothari, Ashish (Ashish Shrikant) |
| author2 | Myron Spector and Carl Berke. |
| author_facet | Myron Spector and Carl Berke. Kothari, Ashish (Ashish Shrikant) |
| author_sort | Kothari, Ashish (Ashish Shrikant) |
| collection | MIT |
| description | Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2011. |
| first_indexed | 2024-09-23T09:06:21Z |
| format | Thesis |
| id | mit-1721.1/65522 |
| institution | Massachusetts Institute of Technology |
| language | eng |
| last_indexed | 2024-09-23T09:06:21Z |
| publishDate | 2011 |
| publisher | Massachusetts Institute of Technology |
| record_format | dspace |
| spelling | mit-1721.1/655222019-04-10T20:47:58Z Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies Impact of the Conformité Européene mark approval on exit opportunities and validation for early stage medical device companies Kothari, Ashish (Ashish Shrikant) Myron Spector and Carl Berke. Harvard University--MIT Division of Health Sciences and Technology. Harvard University--MIT Division of Health Sciences and Technology. Harvard University--MIT Division of Health Sciences and Technology. Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2011. Cataloged from PDF version of thesis. Includes bibliographical references (p. 85-87). The aim of this thesis was to look at the impact of acquiring the CE marking approval on the outcome of early stage medical device companies, specifically its impact on strategic acquisition opportunities and on valuation. We gathered data on acquisitions of 237 companies over the past ten years, from April 01, 2002 to March 31, 2011. These data were gathered from various sources, and information on the date of acquisition, enterprise value, funds invested to date, date of incorporation, status and dates of CE and FDA approvals, patent status, type of regulatory clearances (PMA versus 510K), type of sales models (direct versus distributorship), capitalization status and last twelve month stock returns of the acquirer was acquired. These data were then analyzed using basic statistical methods and multivariate linear regression analyses to determine the significance of the CE marking on the outcomes of these companies. Our results support the claim that the CE mark does significantly improve outcomes for early stage medical device companies, in terms of time to strategic acquisition, which is by far the commonest exit route for these companies. On the other hand, we did not find any statistically significant impact of acquisition of the CE mark on the valuation or valuation multiples of these companies. These results have potential implications for management of these early stage medical device companies in making strategic decisions and for investors who are concerned about the exit opportunities and valuations, especially as it relates to funds invested. There could also be some policy implications in terms of the effort, duration and cost of getting a CE approval versus that of an FDA approval, which is especially important given the current growing concern about increasingly stringent regulation, rising costs and increasing delays in FDA approvals for medical devices. by Ashish Kothari. S.M. 2011-08-30T15:45:47Z 2011-08-30T15:45:47Z 2011 2011 Thesis http://hdl.handle.net/1721.1/65522 746798963 eng M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission. http://dspace.mit.edu/handle/1721.1/7582 87 p. application/pdf Massachusetts Institute of Technology |
| spellingShingle | Harvard University--MIT Division of Health Sciences and Technology. Kothari, Ashish (Ashish Shrikant) Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies |
| title | Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies |
| title_full | Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies |
| title_fullStr | Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies |
| title_full_unstemmed | Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies |
| title_short | Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies |
| title_sort | impact of the ce mark approval on exit opportunities and validation for early stage medical device companies |
| topic | Harvard University--MIT Division of Health Sciences and Technology. |
| url | http://hdl.handle.net/1721.1/65522 |
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